FDA 510(k)

Aqua Medical RF Vapor Ablation System

K-번호: K251226 · 2025-08-08

결정일2025-08-08

제품 코드KNS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

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

자주 묻는 질문

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. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K251226.

When did Aqua Medical RF Vapor Ablation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Aqua Medical RF Vapor Ablation System?

The FDA 510(k) record lists Aqua Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Aqua Medical, Inc.를 신청인으로 등재한 기타 기록

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

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