PKL — Hemostatic Metal Clip For The Gi Tract Class II
FDA product code PKL covers "Hemostatic Metal Clip For The Gi Tract", a Class II medical device regulated under 21 CFR 876.4400. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260580 | olympus medical systems | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX | May 21, 2026 |
| K252270 | hangzhou ags medtech co | Hemoclip | April 8, 2026 |
| 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 |