FDA product code SIM: Gynecologic Power Morcellator And Containment System
SIM is the FDA product code for gynecologic power morcellator and containment system. It is a Class II device, regulated under 21 CFR 884.4075 and reviewed by the Obstetrics and Gynecology panel. Devices under SIM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Gynecologic Power Morcellator And Containment System |
| Device class | Class II |
| Regulation | 21 CFR 884.4075 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for SIM devices
openFDA lists no recalls for product code SIM.
Frequently asked questions
What is FDA product code SIM?
SIM is the FDA product code for gynecologic power morcellator and containment system. It is a Class II device, regulated under 21 CFR 884.4075 and reviewed by the Obstetrics and Gynecology panel.
What device class is SIM?
Class II, regulation 21 CFR 884.4075. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIM
- Run a recall and safety report across every SIM manufacturer
- Watch product code SIM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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