PKL — Hemostatic Metal Clip For The Gi Tract Class II
Classification Details
- Product Code
- PKL
- Device Class
- Class II
- Regulation Number
- 876.4400
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253734 | taurus endoscopy | Taurus Clip | March 12, 2026 |
| K251562 | ovesco endoscopy | OTSCneo System Set (100.03n-14n, 100.27n-31n) | December 18, 2025 |
| K252271 | hangzhou ags medtech co | Hemoclip | November 12, 2025 |
| K250229 | micro-tech (nanjing) co | Dual Action Tissue Closure Device | September 8, 2025 |
| K250842 | steris corporation | PADLOCK CLIP EFTR Kit (00713229) | April 18, 2025 |
| K250066 | boston scientific corporation | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M0052 | February 6, 2025 |
| K241005 | jiangxi zhuoruihua medical instrument co | Haemostasis Clips | January 2, 2025 |
| K240274 | steris corporation | PADLOCK CLIP EFTR Kit (00713229) | September 17, 2024 |
| K241858 | ovesco endoscopy | BARS Set (100.60) | August 26, 2024 |
| K234124 | promisemed hangzhou meditech co | Single Use Hemoclips | July 12, 2024 |
| K232969 | ningbo xinwell medical technology co | Disposable Hemostatic Clips | June 7, 2024 |
| K240617 | olympus medical systems | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX | June 3, 2024 |
| K233772 | mirco-tech (nanjing) co | Disposable Dual Action Tissue Closure Device | March 19, 2024 |
| K232450 | zhejiang soudon medical technology co | Disposable Hemostatic Clips | January 26, 2024 |
| K231633 | alton (shanghai) medical instruments co | Disposable Hemoclip (AF series) | January 11, 2024 |
| K230004 | yangzhou fartley medical instrument technology co | Disposable Hemoclip | July 31, 2023 |
| K222146 | jiangsu vedkang medical science and technology co | Disposable Endoscopic Hemoclip | March 28, 2023 |
| K213217 | beijing zksk technology co | Disposable hemoclip | November 14, 2022 |
| K222503 | boston scientific corporation | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | September 14, 2022 |
| K221124 | boston scientific corporation | MANTIS Clip | August 4, 2022 |