K881014 is an FDA 510(k) clearance for the THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM. This device is classified as a Camera, Television, Endoscopic, Without Audio (Class I - General Controls, product code FWF).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 14, 1988, 35 days after receiving the submission on March 10, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K881014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1988 |
| Decision Date | April 14, 1988 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FWF — Camera, Television, Endoscopic, Without Audio |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |