K162152 is an FDA 510(k) clearance for the Erbe’s CO2 Tubing/Cap Sets. This device is classified as a Pump, Air, Non-manual, For Endoscope (Class II - Special Controls, product code FEQ).
Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on August 31, 2016, 29 days after receiving the submission on August 2, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K162152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2016 |
| Decision Date | August 31, 2016 |
| Days to Decision | 29 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 |