FDA Product Code
FDA Product Code OCW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 70 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | 2026-02-13 | Traditional | PDF ↗ |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy | 2025-04-17 | Traditional | PDF ↗ |
| K231240 | MaxTack Motorized Fixation Device | Covidien | 2023-09-08 | Traditional | PDF ↗ |
| K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 | Traditional | PDF ↗ |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2023-06-29 | Special | PDF ↗ |
| K211309 | endomina system | Endo Tools Therapeutics S.A. | 2021-12-07 | Traditional | PDF ↗ |
| K201744 | Su2ura Approximation Device | Anchora Medical, Ltd. | 2021-06-17 | Traditional | PDF ↗ |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2021-03-02 | Special | PDF ↗ |
| K193652 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2020-03-26 | Traditional | PDF ↗ |
| K191439 | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery | 2019-08-29 | Traditional | PDF ↗ |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | 2018-06-27 | Special | PDF ↗ |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018-02-12 | Traditional | PDF ↗ |
| K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | Sutureease, Inc. | 2017-12-01 | Traditional | PDF ↗ |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017-11-15 | Traditional | PDF ↗ |
| K160117 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2016-09-09 | Traditional | PDF ↗ |
| K160149 | Miret Grasper, Alligator, Miret Grasper, Maryland | Miret Surgical, Inc. | 2016-08-30 | Traditional | PDF ↗ |
| K132232 | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM | Minilap Technologies | 2013-12-04 | Traditional | PDF ↗ |
| K132362 | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | Teleflexmedical, Inc. | 2013-10-08 | Traditional | PDF ↗ |
| K120147 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2012-02-17 | Special | PDF ↗ |
| K110829 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2011-06-03 | Special | PDF ↗ |
| K102931 | G-CINCH SUTURE GRASPER | Usgi Medical | 2010-12-30 | Traditional | PDF ↗ |
| K103412 | AXIOM FASCIAL CLOSURE SYSTEM | Axiom Technology Partners, LLC | 2010-12-30 | Traditional | PDF ↗ |
| K101101 | MINI-TONG | Mini Lap Technologies, Inc. | 2010-07-23 | Traditional | PDF ↗ |
| K082044 | ACE STAPLER, MODEL F0031 | Barosense, Inc. | 2010-05-11 | Traditional | PDF ↗ |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | Endogastric Solutions, Inc. | 2009-07-22 | Special | PDF ↗ |
| K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | Covidien | 2009-05-14 | Traditional | PDF ↗ |
| K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE | Covidien Lp, Formerly Registered AS United States | 2009-03-09 | Special | PDF ↗ |
| K082659 | MODIFIED ENDO STICH | Covidien Lp, Formerly Registered AS United States | 2008-09-19 | Special | PDF ↗ |
| K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | Apollo Endosurgery, Inc. | 2008-08-18 | Traditional | PDF ↗ |
| K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | Endogastric Solutions, Inc. | 2008-06-27 | Traditional | PDF ↗ |
| K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE | Ndo Surgical, Inc. | 2008-03-26 | Traditional | PDF ↗ |
| K070151 | INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER | Ethicon Endo-Surgery, LLC | 2007-08-15 | Traditional | PDF ↗ |
| K070671 | OPUS SMARTSTITCH SUTURE DEVICE | Arthrocare Corp. | 2007-04-06 | Special | PDF ↗ |
| K070352 | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM | Mini Lap Technologies, Inc. | 2007-04-05 | Traditional | PDF ↗ |
| K070686 | MINI LAP INSTRUMENTS | Mini Lap Technologies, Inc. | 2007-04-05 | Traditional | PDF ↗ |
| K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | Endogastric Solutions, Inc. | 2007-03-09 | Traditional | PDF ↗ |
| K062244 | OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR | Arthrocare Corp. | 2006-10-02 | Special | PDF ↗ |
| K061770 | ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM | Ethicon Endo-Surgery, Inc. | 2006-09-25 | Traditional | PDF ↗ |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 | Opus Medical, Inc. | 2003-12-30 | Traditional | PDF ↗ |
| K033269 | ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD | Ethicon Endo-Surgery, Inc. | 2003-12-10 | Traditional | PDF ↗ |
| K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 | Opus Medical, Inc. | 2003-07-28 | Traditional | PDF ↗ |
| K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE | Opus Medical, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | Opus Medical, Inc. | 2002-09-06 | Traditional | PDF ↗ |
| K003949 | TACKER, MODEL R65-933 | A & A Medical, Inc. | 2001-07-25 | Traditional | PDF ↗ |
| K003102 | PARE ENDOSCOPIC SUTURING SYSTEM | Pare Surgical, Inc. | 2001-02-27 | Traditional | PDF ↗ |
| K002398 | ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING | Ethicon Endo-Surgery, Inc. | 2000-11-03 | Traditional | PDF ↗ |
| K000717 | SMITH & NEPHEW SUTURELOK, MODEL 7207321 | Smith & Nephew, Inc. | 2000-03-30 | Special | PDF ↗ |
| K994087 | SUPERSTITCH | Sutura, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K991500 | SMITH & NEPHEW SUTURE LOK | Smith & Nephew Endoscopy, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K980815 | ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER | Ethicon Endo-Surgery, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K974137 | UROMED NEEDLE GRASPER | Uromed Corp. | 1998-01-30 | Traditional | PDF ↗ |
| K973313 | INNOVASIVE DEVICES Y-KNOT SUTURE CLIP | Innovasive Devices, Inc. | 1997-12-01 | Traditional | PDF ↗ |
| K971939 | SMITH & NEPHEW SUTURE COLLET | Smith & Nephew Endoscopy, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K970720 | ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER | Ethicon Endo-Surgery, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K963999 | AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE | United States Surgical, A Division of Tyco Healthc | 1996-11-27 | Traditional | PDF ↗ |
| K962493 | ENDOSCOPIC CLIP APPLIER | Aesculap, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K961390 | ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER | Ethicon Endo-Surgery, Inc. | 1996-06-25 | Traditional | PDF ↗ |
| K960011 | ENDOSCOPIC NEEDLE DRIVER | United States Surgical, A Division of Tyco Healthc | 1996-02-21 | Traditional | PDF ↗ |
| K954641 | ENDO-LEADER | Microsurge, Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K955479 | KOH MICRO-SUTURING INSTRUMENTS | KARL STORZ Endoscopy-America, Inc. | 1995-12-08 | Traditional | PDF ↗ |
| K945202 | ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT | Ethicon Endo-Surgery, Inc. | 1995-01-19 | Traditional | PDF ↗ |
| K944415 | ORIGIN TACKER SYSTEM | Origin Medsystems, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K944435 | DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER | Deroyal Industries, Inc. | 1994-11-15 | Traditional | PDF ↗ |
| K944292 | SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE | Surgical Innovations Corp. | 1994-11-15 | Traditional | PDF ↗ |
| K940967 | MODIFIED ENDOPATH ILS | Ethicon Endo-Surgery, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K935756 | ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT | Ethicon Endo-Surgery, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K934738 | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE | United States Surgical, A Division of Tyco Healthc | 1994-03-16 | Traditional | PDF ↗ |
| K934174 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER | ETHICON, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K932434 | PROXIMATE ARTICULATING LINEAR STAPLER | Ethicon Endo-Surgery, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K935064 | ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION | ETHICON, Inc. | 1994-01-03 | Traditional | PDF ↗ |
Product code OCW · Class II · Gastroenterology, Urology. Data: openFDA.