K182832 is an FDA 510(k) clearance for the Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 26, 2019, 260 days after receiving the submission on October 9, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K182832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 09, 2018 |
| Decision Date | June 26, 2019 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGC — Tube, Gastro-enterostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |