Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZP — Predicate Candidate Screening
177 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
208 days90th percentile
177clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inn | Taiwan Surgical Corporation | 2026-07-20 | 203 | 0 |
| K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | 2025-12-22 | 17 | 0 |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | 2025-12-22 | 26 | 0 |
| K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025-11-20 | 261 | 0 |
| K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | Teleflex Medical | 2025-07-03 | 90 | 0 |
| K242541 | GEM ZIPCLIP | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025-01-15 | 142 | 0 |
| K221495 | SOLID CLIP™ Single Use Clip Applier | Medscope Biotech Co., Ltd. | 2024-07-18 | 787 | 0 |
| K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | 2024-01-12 | 113 | 0 |
| K230966 | angiOCCLUDE Ligating Clips | A2 Medical Systems, LLC | 2023-09-19 | 167 | 0 |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (E | Ethicon Endo Surgery, LLC | 2023-08-29 | 27 | 0 |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05M | Teleflex Medical | 2023-04-28 | 65 | 0 |
| K213813 | DuraFuse Clip and Applier System | Neuramedica, Inc. | 2022-07-22 | 227 | 0 |
| K220006 | angioLOCK Polymer Ligating Clip | A2 Medical Systems, LLC | 2022-03-02 | 57 | 0 |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | Taiwan Surgical Corporation | 2022-01-04 | 460 | 0 |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | M/s. Meril Endo Surgery Private Limited. | 2020-11-23 | 306 | 0 |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Aesculap, Inc. | 2020-09-02 | 33 | 0 |
| K192711 | Dannik Titanium Ligation Clip | Dannik | 2019-12-20 | 84 | 0 |
| K180650 | Amsel Endo Occluder | Amsel Medical Corporation | 2018-11-15 | 247 | 0 |
| K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | Ethicon Endo-Surgery, LLC | 2018-10-30 | 146 | 0 |
| K173323 | AnastoClip GC Closure System | LeMaitre Vascular, Inc. | 2018-03-08 | 139 | 0 |
| K180010 | AtriClip FLEX-V | AtriCure, Inc. | 2018-01-31 | 29 | 0 |
| K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip | AtriCure, Inc. | 2017-10-25 | 27 | 0 |
| K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro | AtriCure, Inc. | 2017-10-11 | 29 | 0 |
| K172479 | Amsel Occluder Device | Amsel Medical | 2017-09-14 | 29 | 0 |
| K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices w | AtriCure, Inc. | 2017-05-19 | 179 | 0 |
| K161758 | Weck Auto Endo10 Automatic Endoscopic Clip Applier | Teleflex Medical | 2016-09-07 | 72 | 0 |
| K151943 | Vas-Q-Clip | Nanova Biomaterials, Inc. | 2016-03-25 | 255 | 0 |
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro | AtriCure, Inc. | 2016-03-18 | 29 | 0 |
| K152082 | Vesocclude Polymer Ligating Clip | Vesocclude Medical, LLC | 2016-02-26 | 214 | 0 |
| K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro | AtriCure, Inc. | 2016-01-27 | 51 | 0 |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Cl | Taiwan Surgical Corporation | 2015-11-06 | 276 | 0 |
| K150936 | SureClip | Conmed Corporation | 2015-10-23 | 199 | 0 |
| K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | Covidien | 2015-09-14 | 266 | 0 |
| K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | Ethicon Endo-Surgery, LLC | 2015-09-10 | 164 | 0 |
| K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | 2015-08-26 | 30 | 0 |
| K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro | AtriCure, Inc. | 2015-06-17 | 63 | 0 |
| K143598 | Lapro-Clip Auto Suture Reusable Long Clip Applier | Covidien, LLC | 2015-03-12 | 84 | 0 |
| K140932 | AMSEL OCCLUDER DEVICE | Amsel Medical Corporation | 2015-01-23 | 287 | 0 |
| K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | 2014-12-19 | 84 | 1 |
| K142869 | Premium Surgiclip III | Covidien | 2014-10-30 | 29 | 0 |
| K142120 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO | AtriCure, Inc. | 2014-08-28 | 24 | 0 |
| K133202 | HEM-O-LOK LIGATING CLIP | Teleflex Medical | 2013-12-03 | 47 | 0 |
| K132658 | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING | Teleflex Medical | 2013-11-27 | 93 | 1 |
| K131107 | ATRICLIP GILLINOV-COSGROVE LAA CLIP | AtriCure, Inc. | 2013-05-14 | 25 | 0 |
| K122276 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO | AtriCure, Inc. | 2012-08-29 | 30 | 0 |
| K121194 | ENDO CLIP III 5MM CLIP APPLIER | Covidien | 2012-05-03 | 14 | 0 |
| K111930 | ACKERMANN EUROPCLIP | Ackermann Instrumente GmbH | 2011-11-08 | 124 | 0 |
| K110699 | LIGAMAX 5 | Ethicon Endo-Sugery, LLC | 2011-03-25 | 11 | 0 |
| K093661 | COLONRING | Niti Surgical Solutions, Ltd. | 2011-02-10 | 442 | 0 |
| K102081 | ENDOSCOPIC CLIP SYSTEM | Aesculap, Inc. | 2010-08-06 | 11 | 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