K801247 is an FDA 510(k) clearance for the CCD ENDOSCOPE AND ATTACHMENTS. This device is classified as a Endoscope, Ac-powered And Accessories (Class II - Special Controls, product code GCP).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 61 days after receiving the submission on May 28, 1980.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K801247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1980 |
| Decision Date | July 28, 1980 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GCP — Endoscope, Ac-powered And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |