SIM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gynecologic Power Morcellator And Containment System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4075
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| Claria System (DEN250034) | Claria Medical, Inc. | 2026-07-02 |
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Every clearance here is in the API, with alerts when new ones post.