Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OCW — Predicate Candidate Screening
70 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
221 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | 2026-02-13 | 197 | 0 |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy | 2025-04-17 | 133 | 0 |
| K231240 | MaxTack™ Motorized Fixation Device | Covidien | 2023-09-08 | 133 | 0 |
| K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 | 700 | 0 |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2023-06-29 | 30 | 0 |
| K211309 | endomina system | Endo Tools Therapeutics S.A. | 2021-12-07 | 221 | 0 |
| K201744 | Su2ura Approximation Device | Anchora Medical, Ltd. | 2021-06-17 | 357 | 0 |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2021-03-02 | 29 | 0 |
| K193652 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2020-03-26 | 87 | 0 |
| K191439 | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery | 2019-08-29 | 91 | 0 |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | 2018-06-27 | 57 | 2 |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with Thu | Teleflexmedical, Inc. | 2018-02-12 | 151 | 0 |
| K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure Sy | Sutureease, Inc. | 2017-12-01 | 87 | 0 |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017-11-15 | 142 | 0 |
| K160117 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2016-09-09 | 234 | 0 |
| K160149 | Miret Grasper, Alligator, Miret Grasper, Maryland | Miret Surgical, Inc. | 2016-08-30 | 222 | 0 |
| K132232 | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM | Minilap Technologies | 2013-12-04 | 139 | 0 |
| K132362 | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | Teleflexmedical, Inc. | 2013-10-08 | 70 | 0 |
| K120147 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2012-02-17 | 30 | 0 |
| K110829 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2011-06-03 | 71 | 0 |
| K102931 | G-CINCH SUTURE GRASPER | Usgi Medical | 2010-12-30 | 87 | 0 |
| K103412 | AXIOM FASCIAL CLOSURE SYSTEM | Axiom Technology Partners, LLC | 2010-12-30 | 38 | 0 |
| K101101 | MINI-TONG | Mini Lap Technologies, Inc. | 2010-07-23 | 94 | 0 |
| K082044 | ACE STAPLER, MODEL F0031 | Barosense, Inc. | 2010-05-11 | 662 | 0 |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTE | Endogastric Solutions, Inc. | 2009-07-22 | 30 | 0 |
| K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVI | Covidien | 2009-05-14 | 80 | 2 |
| K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE | Covidien Lp, Formerly Registered AS United States | 2009-03-09 | 19 | 0 |
| K082659 | MODIFIED ENDO STICH | Covidien Lp, Formerly Registered AS United States | 2008-09-19 | 7 | 0 |
| K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | Apollo Endosurgery, Inc. | 2008-08-18 | 49 | 0 |
| K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | Endogastric Solutions, Inc. | 2008-06-27 | 184 | 0 |
| K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUM | Ndo Surgical, Inc. | 2008-03-26 | 90 | 0 |
| K070151 | INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR | Ethicon Endo-Surgery, LLC | 2007-08-15 | 211 | 0 |
| K070671 | OPUS SMARTSTITCH SUTURE DEVICE | Arthrocare Corp. | 2007-04-06 | 25 | 2 |
| K070686 | MINI LAP INSTRUMENTS | Mini Lap Technologies, Inc. | 2007-04-05 | 24 | 0 |
| K070352 | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM | Mini Lap Technologies, Inc. | 2007-04-05 | 58 | 0 |
| K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | Endogastric Solutions, Inc. | 2007-03-09 | 164 | 0 |
| K062244 | OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR | Arthrocare Corp. | 2006-10-02 | 60 | 0 |
| K061770 | ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM | Ethicon Endo-Surgery, Inc. | 2006-09-25 | 94 | 0 |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM- | Opus Medical, Inc. | 2003-12-30 | 76 | 0 |
| K033269 | ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRID | Ethicon Endo-Surgery, Inc. | 2003-12-10 | 62 | 0 |
| K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 | Opus Medical, Inc. | 2003-07-28 | 192 | 0 |
| K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATIO | Opus Medical, Inc. | 2003-02-14 | 88 | 0 |
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | Opus Medical, Inc. | 2002-09-06 | 58 | 3 |
| K003949 | TACKER, MODEL R65-933 | A & A Medical, Inc. | 2001-07-25 | 216 | 0 |
| K003102 | PARE ENDOSCOPIC SUTURING SYSTEM | Pare Surgical, Inc. | 2001-02-27 | 146 | 0 |
| K002398 | ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTER | Ethicon Endo-Surgery, Inc. | 2000-11-03 | 88 | 0 |
| K000717 | SMITH & NEPHEW SUTURELOK, MODEL 7207321 | Smith & Nephew, Inc. | 2000-03-30 | 27 | 0 |
| K994087 | SUPERSTITCH | Sutura, Inc. | 2000-03-01 | 89 | 0 |
| K991500 | SMITH & NEPHEW SUTURE LOK | Smith & Nephew Endoscopy, Inc. | 1999-07-14 | 76 | 0 |
| K980815 | ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER | Ethicon Endo-Surgery, Inc. | 1998-05-01 | 59 | 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