Product code SIM— Obstetrics/Gynecology
Claria System
- Classification name
- Gynecologic Power Morcellator And Containment System
- Device class
- Class 2
- Regulation
- 21 CFR 884.4075
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SIM
FDA has cleared device under product code SIM, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SIM
Recent clearances under product code SIM
Data sourced from openFDA. This site is unofficial and independent of the FDA.