Data / Medical devices / Gynecologic Power Morcellator And Containment System
Gynecologic Power Morcellator And Containment System (SIM): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Gynecologic Power Morcellator And Containment System (product code SIM, Class 2, 21 CFR 884.4075). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 2, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SIM
- Device class
- 2
- Regulation
- 884.4075
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| Thailand | 1 |
| Taiwan | 1 |
Makers of Gynecologic Power Morcellator And Containment System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Claria Medical | Mountain View, CA, United States | Complaint file establishment, Manufacturer | 1 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Infus Medical (thailand) Co., Ltd. | Amphoe Muang Samutprakarn Samut Prakan, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.