Class Class II
Aqua Medical RF Vapor Ablation System (K251226)
Description
Aqua Medical RF Vapor Ablation System by Aqua Medical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251226
Clearance Date2025-08-08
Clearance TypeTraditional
Product CodeKNS
Regulation Number876.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251226
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Aqua Medical RF Vapor Ablation System (K251226) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | 2021 |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021 |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019 |
Trace the full predicate network for K251226
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.