510(k) K241271

Aqua Medical RF Vapor Ablation System by Aqua Medical, Inc. — Product Code KNS

K241271 is an FDA 510(k) premarket notification submitted by Aqua Medical, Inc. for the device "Aqua Medical RF Vapor Ablation System". The FDA issued a decision of Substantially Equivalent on December 12, 2024. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Aqua Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2024
Date Received
May 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type