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510(k) K251226

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2025
Date Received
April 21, 2025
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

Other clearances by Aqua Medical, Inc.

  • K241271 — Aqua Medical RF Vapor Ablation System (December 12, 2024)
  • K213627 — RF Vapor System (December 17, 2021)
  • K211282 — Aqua Medical RF Vapor System (May 27, 2021)
  • K183595 — Aqua Medical RF Vapor System (June 21, 2019)

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