K860771 is an FDA 510(k) clearance for the VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE. This device is classified as a Endoscope, Flexible (Class II - Special Controls, product code GCQ).
Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on April 23, 1986, 51 days after receiving the submission on March 3, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K860771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1986 |
| Decision Date | April 23, 1986 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GCQ — Endoscope, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |