K160044 is an FDA 510(k) clearance for the Image1 SPIES System. This device is classified as a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II - Special Controls, product code FET).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on February 1, 2016, 24 days after receiving the submission on January 8, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor..
| 510(k) Number | K160044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2016 |
| Decision Date | February 01, 2016 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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. |