SIM — Gynecologic Power Morcellator And Containment System Class II
FDA product code SIM covers "Gynecologic Power Morcellator And Containment System", a Class II medical device regulated under 21 CFR 884.4075. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIM
- Device Class
- Class II
- Regulation Number
- 884.4075
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250034 | claria medical | Claria System | July 2, 2026 |