Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ethicon Endo-Surgery, LLC — Predicate Candidate Screening

70 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

98 daysmedian FDA review time

193 days90th percentile

70clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260196	ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapl	Ethicon Endo-Surgery, LLC	2026-05-11	109	0
K252906	ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)	Ethicon Endo-Surgery, LLC	2026-01-09	119	0
K252739	ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000	Ethicon Endo-Surgery, LLC	2025-12-17	111	0
K250835	ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60	Ethicon Endo-Surgery, LLC	2025-05-14	55	0
K243276	ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR	Ethicon Endo-Surgery, LLC	2025-02-25	132	0
K241630	ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60	Ethicon Endo-Surgery, LLC	2024-10-28	144	0
K241629	ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45m	Ethicon Endo-Surgery, LLC	2024-07-03	27	0
K232313	LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (E	Ethicon Endo Surgery, LLC	2023-08-29	27	0
K230387	ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125	Ethicon Endo-Surgery, LLC	2023-04-13	58	0
K221790	HARMONIC 700 Shears	Ethicon Endo-Surgery, LLC	2023-02-28	252	0
K221343	ECHELON ENDOPATH Staple Line Reinforcement	Ethicon Endo-Surgery, LLC	2022-09-16	130	0
K213633	ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler	Ethicon Endo-Surgery, LLC	2022-04-08	142	0
K211273	Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray	Ethicon Endo-Surgery, LLC	2021-05-21	24	0
K201696	ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, E	Ethicon Endo-Surgery, LLC	2021-01-22	214	0
K201066	ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENS	Ethicon Endo-Surgery, LLC	2021-01-22	275	0
K202665	Echelon Flex 45mm Powered Plus Articulating Endoscopic Linea	Ethicon Endo-Surgery, LLC	2020-10-15	31	0
K201280	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Seale	Ethicon Endo-Surgery, LLC	2020-07-27	75	0
K200420	Echelon Contour Curved Cutter with blue reload, Echelon Cont	Ethicon Endo-Surgery, LLC	2020-06-29	130	0
K200841	Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length	Ethicon Endo-Surgery, LLC	2020-05-11	41	0
K191555	HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Sh	Ethicon Endo-Surgery, LLC	2020-02-28	261	0
K190937	Echelon Endopath Staple Line Reinforcement	Ethicon Endo-Surgery, LLC	2019-10-14	187	0
K183435	Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold,	Ethicon Endo-Surgery, LLC	2019-02-06	57	0
K181488	LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier	Ethicon Endo-Surgery, LLC	2018-10-30	146	0
K181653	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Seale	Ethicon Endo-Surgery, LLC	2018-09-18	88	0
K180403	ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaf	Ethicon Endo-Surgery, LLC	2018-05-23	98	0
K180031	Endopath Electrosurgery Probe Plus II	Ethicon Endo-Surgery, LLC	2018-05-07	123	0
K172580	ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, E	Ethicon Endo-Surgery, LLC	2017-11-20	84	0
K163523	ECHELON CIRCULAR Powered Stapler	Ethicon Endo-Surgery, LLC	2017-04-18	124	0
K163548	ENSEAL X1 Large Jaw Tissue Sealer	Ethicon Endo-Surgery, LLC	2017-02-14	60	0
K163454	ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linea	Ethicon Endo-Surgery, LLC	2017-01-05	27	1
K160554	Enseal X1 Large Jaw Tissue Sealer	Ethicon Endo-Surgery, LLC	2016-09-09	193	0
K160128	Endopath Electrosurgery Probe Plus II	Ethicon Endo-Surgery, LLC	2016-04-28	99	0
K160521	ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic	Ethicon Endo-Surgery, LLC	2016-03-22	26	1
K151136	HARMONIC HOOK	Ethicon Endo-Surgery, LLC	2016-03-04	310	0
K150840	Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier	Ethicon Endo-Surgery, LLC	2015-09-10	164	0
K151340	HARMONIC Focus Long Shears + Adaptive Tissue Technology	Ethicon Endo-Surgery, LLC	2015-07-10	52	0
K150026	Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, E	Ethicon Endo-Surgery, LLC	2015-05-18	131	0
K141122	HARMONIC SCALLOP BLADE, GENERATOR G11	Ethicon Endo-Surgery, LLC	2014-09-15	138	0
K140560	ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUT	Ethicon Endo-Surgery, LLC	2014-04-22	48	2
K132522	HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE	Ethicon Endo-Surgery, LLC	2013-12-16	126	0
K133314	HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY	Ethicon Endo-Surgery, LLC	2013-12-03	36	0
K132512	HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE	Ethicon Endo-Surgery, LLC	2013-10-24	73	0
K131663	ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK	Ethicon Endo-Surgery, LLC	2013-10-18	133	0
K132612	HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS,	Ethicon Endo-Surgery, LLC	2013-10-17	57	1
K131435	ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEAL	Ethicon Endo-Surgery, LLC	2013-10-03	136	0
K130653	ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTE	Ethicon Endo-Surgery, LLC	2013-03-29	17	0
K123212	ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS	Ethicon Endo-Surgery, LLC	2013-03-08	144	0
K122797	ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL	Ethicon Endo-Surgery, LLC	2013-01-25	135	0
K123141	ENSEAL TRIO TISSUE SEALING DEVICE	Ethicon Endo-Surgery, LLC	2012-10-25	20	0
K122511	ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDO	Ethicon Endo-Surgery, LLC	2012-10-01	45	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda