K060673 is an FDA 510(k) clearance for the PEDIATRIC URETERAL STENT, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on March 29, 2006, 15 days after receiving the submission on March 14, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K060673 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2006 |
| Decision Date | March 29, 2006 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAD — Stent, Ureteral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4620 |