DEN250034
- 510(k) number
- DEN250034
- Device name
- Claria System
- Applicant
- Claria Medical, Inc. CA · US
- Product code
- SIM — Gynecologic Power Morcellator And Containment System
- Decision date
- 2026-07-02
- Date received
- 2025-08-07
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Obstetrics/Gynecology
Official FDA record: DEN250034
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.