K053412 is an FDA 510(k) clearance for the FLEXISCOPE, MODELS 50MH AND 50 MHC. This device is classified as a Camera, Television, Endoscopic, Without Audio (Class I - General Controls, product code FWF).
Submitted by Schoelly Imaging, Inc. (Ayer, US). The FDA issued a Cleared decision on February 23, 2006, 78 days after receiving the submission on December 7, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K053412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2005 |
| Decision Date | February 23, 2006 |
| Days to Decision | 78 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 |