K943801 is an FDA 510(k) clearance for the URIGLOW TRANSILLUMINATING URETERIC STENT MODEL, a Light, Catheter, Fiberoptic, Glass, Ureteral (Class II — Special Controls, product code FCS), submitted by Rocket of London, Ltd. (Tyne & Wear, GB). The FDA issued a Cleared decision on August 15, 1995, 377 days after receiving the submission on August 3, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4020.
| 510(k) Number | K943801 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 1994 |
| Decision Date | August 15, 1995 |
| Days to Decision | 377 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCS — Light, Catheter, Fiberoptic, Glass, Ureteral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4020 |