K941506 is an FDA 510(k) clearance for the URETERAL ILLUMINATOR, a Light, Catheter, Fiberoptic, Glass, Ureteral (Class II — Special Controls, product code FCS), submitted by Apple Medical Corp. (Bolton, US). The FDA issued a Cleared decision on October 5, 1994, 190 days after receiving the submission on March 29, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4020.
| 510(k) Number | K941506 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 29, 1994 |
| Decision Date | October 05, 1994 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCS — Light, Catheter, Fiberoptic, Glass, Ureteral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4020 |