FDA Product Code
FDA Product Code PKL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4400
510(k) Clearances — 67 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260487 | stentFIX System Set (100.50n) | Ovesco Endoscopy AG | 2026-10-02 | Traditional | PDF ↗ |
| K261741 | Hemostatic Clip | Anrei Medical (Hz) Co., Ltd. | 2026-10-02 | Traditional | PDF ↗ |
| K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | 2026-09-14 | Traditional | PDF ↗ |
| K254069 | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | 2026-08-10 | Traditional | PDF ↗ |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | 2026-05-21 | Traditional | PDF ↗ |
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 | Traditional | PDF ↗ |
| K253734 | Taurus Clip | Taurus Endoscopy | 2026-03-12 | Traditional | PDF ↗ |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025-12-18 | Traditional | PDF ↗ |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 | Traditional | PDF ↗ |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 | Traditional | PDF ↗ |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2025-04-18 | Special | PDF ↗ |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | 2025-02-06 | Special | PDF ↗ |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 2025-01-02 | Traditional | PDF ↗ |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2024-09-17 | Traditional | PDF ↗ |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | 2024-08-26 | Traditional | PDF ↗ |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 | Traditional | PDF ↗ |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-06-07 | Traditional | PDF ↗ |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | 2024-06-03 | Traditional | PDF ↗ |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024-03-19 | Traditional | PDF ↗ |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | 2024-01-26 | Traditional | PDF ↗ |
| K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-01-11 | Traditional | PDF ↗ |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2023-07-31 | Traditional | PDF ↗ |
| K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023-03-28 | Traditional | PDF ↗ |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | 2022-11-14 | Traditional | PDF ↗ |
| K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | 2022-09-14 | Special | PDF ↗ |
| K221124 | MANTIS Clip | Boston Scientific Corporation | 2022-08-04 | Traditional | PDF ↗ |
| K213143 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022-07-12 | Traditional | PDF ↗ |
| K213338 | CORE-CLIP | Incore Co., Ltd. | 2022-06-23 | Traditional | PDF ↗ |
| K220157 | Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | 2022-06-13 | Traditional | PDF ↗ |
| K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-27 | Traditional | PDF ↗ |
| K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022-03-03 | Traditional | PDF ↗ |
| K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | 2022-01-20 | Traditional | PDF ↗ |
| K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021-08-25 | Special | PDF ↗ |
| K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2021-01-14 | Traditional | PDF ↗ |
| K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2020-12-15 | Traditional | PDF ↗ |
| K201771 | Single Use Rotatable and Repositionable Hemoclip | Anrei Medical (Hangzhou) Co., Ltd. | 2020-10-19 | Traditional | PDF ↗ |
| K200217 | ClearEndoclip | Finemedix Co., Ltd. | 2020-10-05 | Traditional | PDF ↗ |
| K193424 | Resolution 360 ULTRA Clip | Boston Scientific Corporation | 2020-09-01 | Traditional | PDF ↗ |
| K200684 | gastroduodenal FTRD Set | Ovesco Endoscopy AG | 2020-06-02 | Traditional | PDF ↗ |
| K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020-03-05 | Traditional | PDF ↗ |
| K192722 | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | STERIS Corporation | 2019-10-24 | Special | PDF ↗ |
| K183309 | stentfix OTSC System Set | Ovesco Endoscopy AG | 2019-10-22 | Traditional | PDF ↗ |
| K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip | Olympus Medical Systems Corp. | 2019-08-01 | Traditional | PDF ↗ |
| K183021 | ClearEndoclip | Finemedix Co., Ltd. | 2019-06-28 | Traditional | PDF ↗ |
| K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2018-12-14 | Traditional | PDF ↗ |
| K180325 | Single Use MultiClip Device | Micro-Tech (Nanjing) Co., Ltd. | 2018-06-01 | Traditional | PDF ↗ |
| K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2018-04-16 | Traditional | PDF ↗ |
| K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device | STERIS Corporation | 2018-04-12 | Special | PDF ↗ |
| K172762 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-20 | Traditional | PDF ↗ |
| K170867 | FTRD System Set | Ovesco Endoscopy AG | 2017-07-25 | Traditional | PDF ↗ |
| K161463 | SureClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-06 | Traditional | PDF ↗ |
| K153550 | FTRD System Set | Ovesco Endoscopy AG | 2016-10-12 | Traditional | PDF ↗ |
| K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015-12-10 | Traditional | PDF ↗ |
| K150067 | OTSC Proctology | Ovesco Endoscopy AG | 2015-09-16 | Traditional | PDF ↗ |
| K151802 | Resolution Clip | Boston Scientific Corporation | 2015-08-06 | Traditional | PDF ↗ |
| K142973 | Resolution Clip | Boston Scientific Corporation | 2014-12-01 | Traditional | PDF ↗ |
| K132809 | INSTINCT ENDOSCOPIC HEMOCLIP | Wilson-Cook Medical, Inc. | 2013-10-25 | Special | PDF ↗ |
| K123601 | SINGLE USE REPOSITIONABLE CLIP | Olympus Medical Systems Corp. | 2013-04-29 | Traditional | PDF ↗ |
| K122660 | RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 | Boston Scientific Corporation | 2012-12-03 | Traditional | PDF ↗ |
| K120814 | PADLOCK CLIP-12 | Aponos Medical Corp. | 2012-09-06 | Traditional | PDF ↗ |
| K121505 | DISPOSABLE HEMOSTASIS CHIP | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-08-31 | Traditional | PDF ↗ |
| K102764 | RESOLUTION II CLIP | Boston Scientific Corporation | 2010-12-22 | Traditional | PDF ↗ |
| K101428 | OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET | Ovesco Endoscopy AG | 2010-12-01 | Traditional | PDF ↗ |
| K023903 | WILSON-COOK ENDOSCOPIC CLIPPING DEVICE | Wilson-Cook Medical, Inc. | 2003-02-20 | Traditional | PDF ↗ |
| K013889 | ENDOSCOPIC MULTI-FIRE CLIP APPLIER | Inscope, LLC | 2002-02-07 | Traditional | PDF ↗ |
| K990687 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS | Olympus Optical, Co. | 1999-03-26 | Traditional | PDF ↗ |
| K963160 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | Olympus America, Inc. | 1997-06-27 | Traditional | PDF ↗ |
Product code PKL · Class II · Gastroenterology, Urology. Data: openFDA.