K945088 is an FDA 510(k) clearance for the GABRIEL URETERAL ILLUMINATOR SYSTEM II, a Light, Catheter, Fiberoptic, Glass, Ureteral (Class II — Special Controls, product code FCS), submitted by Gabriel Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 7, 1995, 113 days after receiving the submission on October 17, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4020.
| 510(k) Number | K945088 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 17, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 113 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 |