K213338 is an FDA 510(k) clearance for the CORE-CLIP, a Hemostatic Metal Clip For The Gi Tract (Class II — Special Controls, product code PKL), submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 23, 2022, 259 days after receiving the submission on October 7, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K213338 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 2021 |
| Decision Date | June 23, 2022 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PKL — Hemostatic Metal Clip For The Gi Tract |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |
| 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. |