K192183 is an FDA 510(k) clearance for the RocaTub Ureteral Catheter, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Promepal Sam (Monaco, MC). The FDA issued a Cleared decision on April 23, 2020, 255 days after receiving the submission on August 12, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K192183 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2019 |
| Decision Date | April 23, 2020 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |