K012660 is an FDA 510(k) clearance for the GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Gimmi GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on December 20, 2001, 129 days after receiving the submission on August 13, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K012660 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2001 |
| Decision Date | December 20, 2001 |
| Days to Decision | 129 days |
| Submission Type | Abbreviated |
| 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. |