K132340 is an FDA 510(k) clearance for the ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1. 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 December 17, 2013, 144 days after receiving the submission on July 26, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K132340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2013 |
| Decision Date | December 17, 2013 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| 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 |