K913248 is an FDA 510(k) clearance for the CYTOLOGY BRUSH, a Endoscopic Cytology Brush (Class II — Special Controls, product code FDX), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 30, 1991, 70 days after receiving the submission on July 22, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K913248 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 1991 |
| Decision Date | September 30, 1991 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FDX — Endoscopic Cytology Brush |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Collect Cells For Cytological Evaluation. |