K944614 is an FDA 510(k) clearance for the MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM, a Endoscopic Cytology Brush (Class II — Special Controls, product code FDX), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on April 5, 1995, 197 days after receiving the submission on September 20, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K944614 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 1994 |
| Decision Date | April 05, 1995 |
| Days to Decision | 197 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. |