K973504 is an FDA 510(k) clearance for the UROSURGE UROSTENT, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on January 30, 1998, 136 days after receiving the submission on September 16, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K973504 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 1997 |
| Decision Date | January 30, 1998 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FAD — Stent, Ureteral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4620 |