Aqua Medical, Inc. · Class II · Cleared Aug 8, 2025
| K-number | K251226 |
| Device name | Aqua Medical RF Vapor Ablation System |
| Applicant | Aqua Medical, Inc. |
| Product code | KNS |
| Device class | Class II |
| Decision date | Aug 8, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
The Aqua Medical RF Vapor Ablation System is a catheter-based device that uses radiofrequency energy to heat saline, creating steam for coagulation and ablation of bleeding and non-bleeding lesions in the gastrointestinal tract. It is indicated for treatment of conditions including esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, Barrett's esophagus, and radiation proctitis in adults only.
The device comprises an RF generator with graphical user interface and syringe pump, disposable 7F catheters (10.5F outer sheath, 145-210 cm length) compatible with 3.7mm endoscope working channels, and a cassette system with tubing and 60cc syringe. This submission focused on modifications to the generator, cassette, and circumferential catheter design compared to the predicate.
Not stated in this summary.
The modifications to the generator, cassette, and circumferential catheter do not introduce new safety or effectiveness concerns because Aqua Medical conducted supporting non-clinical testing including EMC and electrical safety, software validation, hardware verification, simulated-use tissue validation (lean beef testing), biocompatibility, shelf-life assessment, and sterilization validation. The company demonstrated that these requested modifications are adequately supported by bench testing and scientific rationale, maintaining substantial equivalence to the predicate device.
View the full FDA submission: accessdata.fda.gov