Aqua Medical RF Vapor Ablation System— 510(k) K251226

Name: FDA 510(k) clearance K251226
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Substantially Equivalent

Aqua Medical, Inc.

FDA 510(k) clearance K251226 for Aqua Medical RF Vapor Ablation System, Substantially Equivalent on 2025-08-08. Applicant: Aqua Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aqua Medical, Inc.
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-21
Decision date: 2025-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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K262460 — Rezum System2026-09-03
K260962 — Sphincterotome2026-05-21
K252388 — Vanquish Water Vapor Ablation Device2025-11-26
K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17

More clearances from Aqua Medical, Inc.

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K241271 — Aqua Medical RF Vapor Ablation System2024-12-12
K213627 — RF Vapor System2021-12-17
K211282 — Aqua Medical RF Vapor System2021-05-27
K183595 — Aqua Medical RF Vapor System2019-06-21

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.