K213627 is an FDA 510(k) clearance for the RF Vapor System, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Aqua Medical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 17, 2021, 30 days after receiving the submission on November 17, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K213627 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2021 |
| Decision Date | December 17, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |