K946293 is an FDA 510(k) clearance for the MILL-ROSE SCOPE CLEANING BRUSH, a Accessories, Cleaning Brushes, For Endoscope (Class I — General Controls, product code MNL), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on February 16, 1995, 51 days after receiving the submission on December 27, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K946293 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 1994 |
| Decision Date | February 16, 1995 |
| Days to Decision | 51 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 |