Cleared Special

Aqua Medical RF Vapor System

K211282 · Aqua Medical, Inc. · Gastroenterology & Urology
May 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K211282 is an FDA 510(k) clearance for the Aqua Medical 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 May 27, 2021, 30 days after receiving the submission on April 27, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K211282 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2021
Decision Date May 27, 2021
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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