Sterile Repositionable Hemostasis Clipping Device
FDA 510(k) K152001 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK152001
Submission
- Device name
- Sterile Repositionable Hemostasis Clipping Device
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- July 20, 2015
- Decision date
- December 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKL – Hemostatic Metal Clip For The Gi Tract
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Other 510(k)s with product code PKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254069 | Hemoclip (511 series, 543 series)PKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 08/10/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | Olympus Medical Systems Corp. | 05/21/2026SE |
| K252270 | HemoclipPKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 04/08/2026SE |
| K253734 | Taurus ClipPKL · Traditional | Taurus Endoscopy | 03/12/2026SE |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n)PKL · Traditional | Ovesco Endoscopy AG | 12/18/2025SE |
| K252271 | HemoclipPKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 11/12/2025SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 09/08/2025SE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229)PKL · Special | STERIS Corporation | 04/18/2025SE |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602)…PKL · Special | Boston Scientific Corporation | 02/06/2025SE |
| K241005 | Haemostasis ClipsPKL · Traditional | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 01/02/2025SE |
More from Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital ControllerSHU · Traditional | 04/24/2026SE |
| K251692 | Advanced Tissue Resection DeviceFDI · Traditional | 02/21/2026SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | 09/08/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | 06/27/2025SE |
| K243471 | Extraction BasketLQR · Traditional | 12/16/2024SE |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…FGE · Traditional | 09/06/2023SE |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN · Traditional | 02/16/2023SE |
| K222354 | Elastic Traction SystemQSW · Traditional | 10/03/2022SE |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…KTI · Traditional | 07/20/2022SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | 07/08/2022SE |
Questions and answers
When was Sterile Repositionable Hemostasis Clipping Device cleared by the FDA?
Sterile Repositionable Hemostasis Clipping Device (K152001) received a 510(k) decision of Substantially Equivalent on December 10, 2015, 143 days after the submission was received.
What is the product code of K152001?
The FDA product code is PKL – Hemostatic Metal Clip For The Gi Tract, a Class II (moderate risk) device regulated under 21 CFR 876.4400.