K935250 is an FDA 510(k) clearance for the ACCU-PATH. This device is classified as a Forceps, Biopsy, Non-electric (Class I - General Controls, product code FCL).
Submitted by Cox Medical Ent., Inc. (Ventura, US). The FDA issued a Cleared decision on January 21, 1994, 81 days after receiving the submission on November 1, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K935250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1993 |
| Decision Date | January 21, 1994 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1075 |