Aqua Medical RF Vapor Ablation System— 510(k) K241271
Substantially EquivalentAqua Medical, Inc.
FDA 510(k) clearance K241271 for Aqua Medical RF Vapor Ablation System, Substantially Equivalent on 2024-12-12. Applicant: Aqua Medical, Inc..
Clearance details
- Applicant
- Aqua Medical, Inc.
- Product code
- Code KNS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.