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FDA 510(k)

Aqua Medical RF Vapor Ablation System

K-Number: K251226 · 2025-08-08

ApplicantAqua Medical, Inc.
Decision Date2025-08-08
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aqua Medical RF Vapor Ablation System is a medical device manufactured by Aqua Medical, Inc.. It received FDA 510(k) clearance on 2025-08-08 under approval number K251226. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aqua Medical RF Vapor Ablation System?

Aqua Medical RF Vapor Ablation System is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Aqua Medical, Inc.. The 510(k) number is K251226.

When was Aqua Medical RF Vapor Ablation System approved by the FDA?

Aqua Medical RF Vapor Ablation System received FDA 510(k) clearance on 2025-08-08, under approval number K251226.

What company makes Aqua Medical RF Vapor Ablation System?

Aqua Medical RF Vapor Ablation System is manufactured by Aqua Medical, Inc..

What is the FDA product code for Aqua Medical RF Vapor Ablation System?

The FDA product code for Aqua Medical RF Vapor Ablation System is KNS.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Aqua Medical, Inc.

K183595Aqua Medical RF Vapor System K213627RF Vapor System K211282Aqua Medical RF Vapor System K241271Aqua Medical RF Vapor Ablation System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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