Submission Details
| 510(k) Number | K220395 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
EndoGator Endoscopy Irrigation Tubing
Mar 2022
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K220395 is an FDA 510(k) clearance for the EndoGator Endoscopy Irrigation Tubing, 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 review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | FEQ — Pump, Air, Non-manual, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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