K885168 is an FDA 510(k) clearance for the RUBENSTEIN URETERAL STONE FRAGMENT BRUSH. This device is classified as a Dislodger, Stone, Flexible (Class II - Special Controls, product code FGO).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on September 8, 1989, 269 days after receiving the submission on December 13, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K885168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1988 |
| Decision Date | September 08, 1989 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FGO — Dislodger, Stone, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |