# K251226: Aqua Medical RF Vapor Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Aqua Medical, Inc.
- Decided: Aug 8, 2025 after 109 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213627: RF Vapor System, Aqua Medical, Inc. (2021) Summary page 5.
- K211282: Aqua Medical RF Vapor System, Aqua Medical, Inc. (2021) Summary page 5.
- K183595: Aqua Medical RF Vapor System, Aqua Medical, Inc. (2019) Summary page 5.
- K241271: Aqua Medical RF Vapor Ablation System, Aqua Medical, Inc. (2024) Summary page 5.

## Indications for use
The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.

Source page: https://510kreport.com/device/K251226
Methodology: https://510kreport.com/methodology