K220395 is an FDA 510(k) clearance for the EndoGator Endoscopy Irrigation Tubing. This device is classified as a Pump, Air, Non-manual, For Endoscope (Class II - Special Controls, product code FEQ).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 11, 2022, 28 days after receiving the submission on February 11, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K220395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2022 |
| Decision Date | March 11, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEQ — Pump, Air, Non-manual, For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |