K173105 is an FDA 510(k) clearance for the Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 22, 2018, 174 days after receiving the submission on September 29, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K173105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | March 22, 2018 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC — Endoscope Channel Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |