K223916 is an FDA 510(k) clearance for the PUMA-G System. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by Coaptech, Inc. (Baltimore, US). The FDA issued a Cleared decision on March 29, 2023, 90 days after receiving the submission on December 29, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K223916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2022 |
| Decision Date | March 29, 2023 |
| Days to Decision | 90 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 |