K950689 is an FDA 510(k) clearance for the UCB, a Accessories, Cleaning Brushes, For Endoscope (Class I — General Controls, product code MNL), submitted by Cox Medical Ent., Inc. (Ventura, US). The FDA issued a Cleared decision on March 6, 1995, 20 days after receiving the submission on February 14, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K950689 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 1995 |
| Decision Date | March 06, 1995 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MNL — Accessories, Cleaning Brushes, For Endoscope |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1500 |