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Ethicon Endo-Surgery, LLC

70 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) (K260196)Ethicon Endo-Surgery, LLC2026-05-11
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (K252906)Ethicon Endo-Surgery, LLC2026-01-09
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) (K252739)Ethicon Endo-Surgery, LLC2025-12-17
ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) (K250835)Ethicon Endo-Surgery, LLC2025-05-14
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) (K243276)Ethicon Endo-Surgery, LLC2025-02-25
ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) (K241630)Ethicon Endo-Surgery, LLC2024-10-28
ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) (K241629)Ethicon Endo-Surgery, LLC2024-07-03
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313)Ethicon Endo Surgery, LLC2023-08-29
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) (K230387)Ethicon Endo-Surgery, LLC2023-04-13
HARMONIC 700 Shears (K221790)Ethicon Endo-Surgery, LLC2023-02-28
ECHELON ENDOPATH Staple Line Reinforcement (K221343)Ethicon Endo-Surgery, LLC2022-09-16
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (K213633)Ethicon Endo-Surgery, LLC2022-04-08
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray (K211273)Ethicon Endo-Surgery, LLC2021-05-21
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length (K201696)Ethicon Endo-Surgery, LLC2021-01-22
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length (K201066)Ethicon Endo-Surgery, LLC2021-01-22
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm (K202665)Ethicon Endo-Surgery, LLC2020-10-15
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K201280)Ethicon Endo-Surgery, LLC2020-07-27
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green (K200420)Ethicon Endo-Surgery, LLC2020-06-29
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 (K200841)Ethicon Endo-Surgery, LLC2020-05-11
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length (K191555)Ethicon Endo-Surgery, LLC2020-02-28
Echelon Endopath Staple Line Reinforcement (K190937)Ethicon Endo-Surgery, LLC2019-10-14
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black (K183435)Ethicon Endo-Surgery, LLC2019-02-06
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier (K181488)Ethicon Endo-Surgery, LLC2018-10-30
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K181653)Ethicon Endo-Surgery, LLC2018-09-18
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length (K180403)Ethicon Endo-Surgery, LLC2018-05-23
Endopath Electrosurgery Probe Plus II (K180031)Ethicon Endo-Surgery, LLC2018-05-07
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length (K172580)Ethicon Endo-Surgery, LLC2017-11-20
ECHELON CIRCULAR Powered Stapler (K163523)Ethicon Endo-Surgery, LLC2017-04-18
ENSEAL X1 Large Jaw Tissue Sealer (K163548)Ethicon Endo-Surgery, LLC2017-02-14
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm (K163454)Ethicon Endo-Surgery, LLC2017-01-05
Enseal X1 Large Jaw Tissue Sealer (K160554)Ethicon Endo-Surgery, LLC2016-09-09
Endopath Electrosurgery Probe Plus II (K160128)Ethicon Endo-Surgery, LLC2016-04-28
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm (K160521)Ethicon Endo-Surgery, LLC2016-03-22
HARMONIC HOOK (K151136)Ethicon Endo-Surgery, LLC2016-03-04
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier (K150840)Ethicon Endo-Surgery, LLC2015-09-10
HARMONIC Focus Long Shears + Adaptive Tissue Technology (K151340)Ethicon Endo-Surgery, LLC2015-07-10
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler (K150026)Ethicon Endo-Surgery, LLC2015-05-18
HARMONIC SCALLOP BLADE, GENERATOR G11 (K141122)Ethicon Endo-Surgery, LLC2014-09-15
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING (K140560)Ethicon Endo-Surgery, LLC2014-04-22
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132522)Ethicon Endo-Surgery, LLC2013-12-16
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY (K133314)Ethicon Endo-Surgery, LLC2013-12-03
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132512)Ethicon Endo-Surgery, LLC2013-10-24
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK (K131663)Ethicon Endo-Surgery, LLC2013-10-18
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612)Ethicon Endo-Surgery, LLC2013-10-17
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, (K131435)Ethicon Endo-Surgery, LLC2013-10-03
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU (K130653)Ethicon Endo-Surgery, LLC2013-03-29
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS (K123212)Ethicon Endo-Surgery, LLC2013-03-08
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW (K122797)Ethicon Endo-Surgery, LLC2013-01-25
ENSEAL TRIO TISSUE SEALING DEVICE (K123141)Ethicon Endo-Surgery, LLC2012-10-25
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH (K122511)Ethicon Endo-Surgery, LLC2012-10-01
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY (K121550)Ethicon Endo-Surgery, LLC2012-08-22
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE (K121600)Ethicon Endo-Surgery, LLC2012-07-16
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 (K120729)Ethicon Endo-Surgery, LLC2012-05-17
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL (K112056)Ethicon Endo-Surgery, LLC2011-12-19
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO (K111111)Ethicon Endo-Surgery, LLC2011-06-08
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET (K103672)Ethicon Endo-Surgery, LLC2011-04-08
REUSABLE LINEAR STAPLER HANDLE (K110049)Ethicon Endo-Surgery, LLC2011-02-10
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING (K093899)Ethicon Endo-Surgery, LLC2010-04-29
HARMONIC FOCUS SHEARS (K100597)Ethicon Endo-Surgery, LLC2010-04-07
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) (K092577)Ethicon Endo-Surgery, LLC2009-09-15
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) (K081146)Ethicon Endo-Surgery, LLC2008-06-26
ECHELON GRAY CARTRIDGE, MODEL ERC45M (K080839)Ethicon Endo-Surgery, LLC2008-05-21
HARMONIC 10CM COMBINATION HOOK BLADE (K072203)Ethicon Endo-Surgery, LLC2007-09-25
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER (K070151)Ethicon Endo-Surgery, LLC2007-08-15
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 (K070198)Ethicon Endo-Surgery, LLC2007-06-13
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) (K070887)Ethicon Endo-Surgery, LLC2007-05-25
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G (K062869)Ethicon Endo-Surgery, LLC2007-02-26
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP (K063192)Ethicon Endo-Surgery, LLC2007-01-30
BASX BLADELESS TROCAR (K062209)Ethicon Endo-Surgery, LLC2006-10-10
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES (K061192)Ethicon Endo-Surgery, LLC2006-05-23

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Every clearance here is in the API, with alerts when new ones post.