# K183595: Aqua Medical RF Vapor System

- Pathway: 510(k) (Traditional)
- Applicant: Aqua Medical, Inc.
- Decided: Jun 21, 2019 after 182 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: 17 generations back to K943450 (1995). 40 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060169: Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F, Barrx Medical, Incorporated (2006) Summary page 4.
- K093008: Halo Ablation Catheter, Model 90-9100, Barrx Medical, Incorporated (2010) Summary page 4.

## Most influential descendants
- K211282: Aqua Medical RF Vapor System (2021), 3 descendants of its own
- K213627: RF Vapor System (2021), 2 descendants of its own
- K241271: Aqua Medical RF Vapor Ablation System (2024), 1 descendant of its own
- K251226: Aqua Medical RF Vapor Ablation System (2025), 0 descendants of its own

## Indications for use
The Aqua Medical RF Vapor System is indicated for use in the coagulation 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/K183595
Methodology: https://510kreport.com/methodology