# K213627: RF Vapor System

- Pathway: 510(k) (Special)
- Applicant: Aqua Medical, Inc.
- Decided: Dec 17, 2021 after 30 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: 19 generations back to K943450 (1995). 42 ancestors in all.
2 later devices descend from it; 2 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)
- K211282: Aqua Medical RF Vapor System, Aqua Medical, Inc. (2021) Summary page 4.
- K183595: Aqua Medical RF Vapor System, Aqua Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- 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/K213627
Methodology: https://510kreport.com/methodology