FDA 510(k) Applications for Medical Device Product Code "PKL"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K201771 | Anrei Medical (Hangzhou) Co., Ltd. | Single Use Rotatable and Repositionable Hemoclip | 10/19/2020 |
| K201808 | Apollo Endosurgery, Inc. | X-Tack Endoscopic HeliX Tacking System | 12/15/2020 |
| K120814 | APONOS MEDICAL CORP. | PADLOCK CLIP-12 | 09/06/2012 |
| K213217 | Beijing ZKSK Technology Co.,Ltd | Disposable hemoclip | 11/14/2022 |
| K221124 | Boston Scientific Corporation | MANTIS Clip | 08/04/2022 |
| K193424 | Boston Scientific Corporation | Resolution 360Ö ULTRA Clip | 09/01/2020 |
| K142973 | Boston Scientific Corporation | Resolution Clip | 12/01/2014 |
| K151802 | BOSTON SCIENTIFIC CORPORATION | Resolution Clip | 08/06/2015 |
| K122660 | Boston Scientific Corporation | RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 | 12/03/2012 |
| K222503 | Boston Scientific Corporation | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | 09/14/2022 |
| K102764 | Boston Scientific Corporation | RESOLUTION II CLIP | 12/22/2010 |
| K192697 | Cook Endoscopy | Instinct Plus Endoscopic Clipping Device | 03/05/2020 |
| K183021 | Finemedix Co., Ltd. | ClearEndoclip | 06/28/2019 |
| K200217 | Finemedix Co., Ltd. | ClearEndoclip | 10/05/2020 |
| K172727 | Hangzhou AGS MedTech CO., Ltd | Hemoclip | 04/16/2018 |
| K211787 | Hangzhou AGS MedTech Co., Ltd. | Hemoclip | 03/03/2022 |
| K213143 | Hangzhou AGS MedTech Co., Ltd. | Hemoclip | 07/12/2022 |
| K213338 | Incore Co., Ltd. | CORE-CLIP | 06/23/2022 |
| K013889 | INSCOPE, LLC. | ENDOSCOPIC MULTI-FIRE CLIP APPLIER | 02/07/2002 |
| K222146 | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Disposable Endoscopic Hemoclip | 03/28/2023 |
| K180325 | Micro-Tech (Nanjing) CO., Ltd | Single Use MultiClip Device | 06/01/2018 |
| K212748 | Micro-Tech (Nanjing) Co., Ltd. | Disposable Dual Action Tissue Clip | 01/20/2022 |
| K220157 | Micro-Tech (Nanjing) Co., Ltd. | Disposable Hemostatic Closure Clip Device | 06/13/2022 |
| K202333 | Micro-Tech (Nanjing) Co., Ltd. | Lockado Repositionable Hemostasis Clip | 01/14/2021 |
| K182556 | Micro-Tech (Nanjing) CO., Ltd. | SureClip Repositionable Hemostasis Clip | 12/14/2018 |
| K161463 | Micro-Tech (Nanjing) CO., Ltd. | SureClip(TM) Repositionable Hemostasis Clip | 01/06/2017 |
| K152001 | Micro-Tech (Nanjing) CO.,Ltd. | Sterile Repositionable Hemostasis Clipping Device | 12/10/2015 |
| K963160 | OLYMPUS AMERICA, INC. | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | 06/27/1997 |
| K183590 | Olympus Medical Systems Corp. | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip | 08/01/2019 |
| K123601 | OLYMPUS MEDICAL SYSTEMS CORP. | SINGLE USE REPOSITIONABLE CLIP | 04/29/2013 |
| K990687 | OLYMPUS OPTICAL, CO. | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS | 03/26/1999 |
| K153550 | OVESCO ENDOSCOPY AG | FTRD System Set | 10/12/2016 |
| K170867 | Ovesco Endoscopy AG | FTRD System Set | 07/25/2017 |
| K200684 | Ovesco Endoscopy AG | gastroduodenal FTRD Set | 06/02/2020 |
| K101428 | OVESCO ENDOSCOPY AG | OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET | 12/01/2010 |
| K150067 | OVESCO ENDOSCOPY AG | OTSC Proctology | 09/16/2015 |
| K183309 | Ovesco Endoscopy AG | stentfix OTSC System Set | 10/22/2019 |
| K180689 | STERIS Corporation | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device | 04/12/2018 |
| K192722 | STERIS Corporation | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | 10/24/2019 |
| K132809 | WILSON-COOK MEDICAL INC. | INSTINCT ENDOSCOPIC HEMOCLIP | 10/25/2013 |
| K212323 | Wilson-Cook Medical Inc. | Instinct Plus Endoscopic Clipping Device | 08/25/2021 |
| K023903 | WILSON-COOK MEDICAL, INC. | WILSON-COOK ENDOSCOPIC CLIPPING DEVICE | 02/20/2003 |
| K121505 | WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY | DISPOSABLE HEMOSTASIS CHIP | 08/31/2012 |
| K230004 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Disposable Hemoclip | 07/31/2023 |
| K172762 | Zhejiang Chuangxiang Medical Technology Co., LTD. | Single Use Hemoclip | 03/20/2018 |
| K212669 | Zhejiang Chuangxiang Medical Technology Co., LTD. | Single Use Hemoclip | 05/27/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
