K990154 is an FDA 510(k) clearance for the KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM, a Camera, Television, Endoscopic, Without Audio (Class I — General Controls, product code FWF), submitted by Karl Storz Imaging, Inc. (Goleta, US). The FDA issued a Cleared decision on June 1, 1999, 133 days after receiving the submission on January 19, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K990154 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 19, 1999 |
| Decision Date | June 01, 1999 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWF — Camera, Television, Endoscopic, Without Audio |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4160 |