K892069 is an FDA 510(k) clearance for the EXTENDED COVERS, STERILE. This device is classified as a Cover, Biopsy Forceps (Class I - General Controls, product code FFF).
Submitted by Amedic USA (Sweden, SE). The FDA issued a Cleared decision on August 8, 1989, 130 days after receiving the submission on March 31, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K892069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1989 |
| Decision Date | August 08, 1989 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFF — Cover, Biopsy Forceps |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1075 |