510(k) DEN250034
DEN250034 is an FDA 510(k) premarket notification submitted by Claria Medical, Inc. for the device "Claria System". The FDA issued a decision of De Novo Granted on July 2, 2026. The device falls under product code SIM (Gynecologic Power Morcellator And Containment System), a Class II device regulated under 21 CFR 884.4075.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 2, 2026
- Date Received
- August 7, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gynecologic Power Morcellator And Containment System
- Device Class
- Class II
- Regulation Number
- 884.4075
- Review Panel
- OB
- Submission Type
A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery.