Atlas FDA

OCW

70 FDA 510(k) clearances · Product code

87 daysmedian time to decision
221 days90th percentile
70clearances measured

FDA profile

Official device name
Endoscopic Tissue Approximation Device
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Adverse events (MAUDE)
2021: 198 · 2022: 235 · 2023: 227 · 2024: 211 · 2025: 329 · 2026: 337
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Endomina EZFuse system (K252400)Endo Tools Therapeutics S.A.2026-02-13
SimpleStitch Suturing System (K243750)Envision Endoscopy2025-04-17
MaxTack™ Motorized Fixation Device (K231240)Covidien2023-09-08
MedicloseTM System (K213271)Health Value Creation B.V., Trading AS Corporis Medical2023-08-31
OverStitch NXT Endoscopic Suturing System (K231553)Apollo Endosurgery, Inc.2023-06-29
endomina system (K211309)Endo Tools Therapeutics S.A.2021-12-07
Su2ura Approximation Device (K201744)Anchora Medical, Ltd.2021-06-17
OverStitch Sx Endoscopic Suturing System (K210266)Apollo Endosurgery, Inc.2021-03-02
AbClose - Port Site Closure Device (K193652)Medeon Biodesign, Inc.2020-03-26
OverStitch 2-0 Polypropylene Suture (K191439)Apollo Endosurgery2019-08-29
OverStitch Endoscopic Suturing System and Accessories (K181141)Apollo Endosurgery2018-06-27
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (K172775)Teleflexmedical, Inc.2018-02-12
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor (K172666)Sutureease, Inc.2017-12-01
OverStitch SX Endoscopic Suturing System (ESS) (K171886)Apollo Endosurgery, Inc.2017-11-15
AbClose - Port Site Closure Device (K160117)Medeon Biodesign, Inc.2016-09-09
Miret Grasper, Alligator, Miret Grasper, Maryland (K160149)Miret Surgical, Inc.2016-08-30
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM (K132232)Minilap Technologies2013-12-04
WECK EFX ENDO FASCIAL CLOSURE SYSTEM (K132362)Teleflexmedical, Inc.2013-10-08
ACE STAPLER AND CARTRIDGE (K120147)Barosense, Inc.2012-02-17
ACE STAPLER AND CARTRIDGE (K110829)Barosense, Inc.2011-06-03
G-CINCH SUTURE GRASPER (K102931)Usgi Medical2010-12-30
AXIOM FASCIAL CLOSURE SYSTEM (K103412)Axiom Technology Partners, LLC2010-12-30
MINI-TONG (K101101)Mini Lap Technologies, Inc.2010-07-23
ACE STAPLER, MODEL F0031 (K082044)Barosense, Inc.2010-05-11
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER (K091832)Endogastric Solutions, Inc.2009-07-22
AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES (K090470)Covidien2009-05-14
SILS STITCH ENDOSCOPIC SUTURING DEVICE (K090419)Covidien Lp, Formerly Registered AS United States2009-03-09
MODIFIED ENDO STICH (K082659)Covidien Lp, Formerly Registered AS United States2008-09-19
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM (K081853)Apollo Endosurgery, Inc.2008-08-18
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES (K073644)Endogastric Solutions, Inc.2008-06-27
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE (K073671)Ndo Surgical, Inc.2008-03-26
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER (K070151)Ethicon Endo-Surgery, LLC2007-08-15
OPUS SMARTSTITCH SUTURE DEVICE (K070671)Arthrocare Corp.2007-04-06
MINI LAP INSTRUMENTS (K070686)Mini Lap Technologies, Inc.2007-04-05
MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM (K070352)Mini Lap Technologies, Inc.2007-04-05
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES (K062875)Endogastric Solutions, Inc.2007-03-09
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR (K062244)Arthrocare Corp.2006-10-02
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM (K061770)Ethicon Endo-Surgery, Inc.2006-09-25
SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 (K033317)Opus Medical, Inc.2003-12-30
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD (K033269)Ethicon Endo-Surgery, Inc.2003-12-10
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 (K030170)Opus Medical, Inc.2003-07-28
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE (K023843)Opus Medical, Inc.2003-02-14
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 (K022229)Opus Medical, Inc.2002-09-06
TACKER, MODEL R65-933 (K003949)A & A Medical, Inc.2001-07-25
PARE ENDOSCOPIC SUTURING SYSTEM (K003102)Pare Surgical, Inc.2001-02-27
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING (K002398)Ethicon Endo-Surgery, Inc.2000-11-03
SMITH & NEPHEW SUTURELOK, MODEL 7207321 (K000717)Smith & Nephew, Inc.2000-03-30
SUPERSTITCH (K994087)Sutura, Inc.2000-03-01
SMITH & NEPHEW SUTURE LOK (K991500)Smith & Nephew Endoscopy, Inc.1999-07-14
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER (K980815)Ethicon Endo-Surgery, Inc.1998-05-01
UROMED NEEDLE GRASPER (K974137)Uromed Corp.1998-01-30
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP (K973313)Innovasive Devices, Inc.1997-12-01
SMITH & NEPHEW SUTURE COLLET (K971939)Smith & Nephew Endoscopy, Inc.1997-08-06
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER (K970720)Ethicon Endo-Surgery, Inc.1997-06-27
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE (K963999)United States Surgical, A Division of Tyco Healthc1996-11-27
ENDOSCOPIC CLIP APPLIER (K962493)Aesculap, Inc.1996-09-11
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER (K961390)Ethicon Endo-Surgery, Inc.1996-06-25
ENDOSCOPIC NEEDLE DRIVER (K960011)United States Surgical, A Division of Tyco Healthc1996-02-21
ENDO-LEADER (K954641)Microsurge, Inc.1995-12-28
KOH MICRO-SUTURING INSTRUMENTS (K955479)KARL STORZ Endoscopy-America, Inc.1995-12-08
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT (K945202)Ethicon Endo-Surgery, Inc.1995-01-19
ORIGIN TACKER SYSTEM (K944415)Origin Medsystems, Inc.1994-11-28
SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE (K944292)Surgical Innovations Corp.1994-11-15
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER (K944435)Deroyal Industries, Inc.1994-11-15
MODIFIED ENDOPATH ILS (K940967)Ethicon Endo-Surgery, Inc.1994-05-27
ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT (K935756)Ethicon Endo-Surgery, Inc.1994-04-21
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE (K934738)United States Surgical, A Division of Tyco Healthc1994-03-16
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER (K934174)ETHICON, Inc.1994-03-09
PROXIMATE ARTICULATING LINEAR STAPLER (K932434)Ethicon Endo-Surgery, Inc.1994-02-07
ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION (K935064)ETHICON, Inc.1994-01-03

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