K160275 is an FDA 510(k) clearance for the Fuse Endoscopic System with FuseBox Processor, a Endoscope, Accessories, Image Post-processing For Color Enhancement (Class II — Special Controls, product code PEA), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 1, 2016, 181 days after receiving the submission on February 2, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K160275 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 02, 2016 |
| Decision Date | August 01, 2016 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PEA — Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement. |