K183057 is an FDA 510(k) clearance for the PUMA-G System, a Tube, Gastro-enterostomy (Class II — Special Controls, product code KGC), submitted by Coaptech, LLC (Baltimore, US). The FDA issued a Cleared decision on April 10, 2019, 159 days after receiving the submission on November 2, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K183057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2018 |
| Decision Date | April 10, 2019 |
| Days to Decision | 159 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 |