K994090 is an FDA 510(k) clearance for the KARL STORZ AUTOCLAVABLE CAMERA HEAD, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Karl Storz Imaging, Inc. (Goleta, US). The FDA issued a Cleared decision on February 4, 2000, 63 days after receiving the submission on December 3, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K994090 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 1999 |
| Decision Date | February 04, 2000 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FET — Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor. |