Data / Medical devices / Containment System, Laparoscopic Power Morcellation, With Instrument Port
Containment System, Laparoscopic Power Morcellation, With Instrument Port (PMU): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Containment System, Laparoscopic Power Morcellation, With Instrument Port (product code PMU, Class 2, 21 CFR 884.4050). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 15, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PMU
- Device class
- 2
- Regulation
- 884.4050
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Austria | 1 |
| Israel | 1 |
Makers of Containment System, Laparoscopic Power Morcellation, With Instrument Port
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 |
|---|---|---|---|---|---|---|---|---|
| A.M.I. Agency For Medical Innovations GMBH | Feldkirch Vorarlberg, Austria | Manufacturer | 1 | November 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ark Surgical | Nazareth Haifa, Israel | Manufacturer | 1 | April 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Claria Medical | Mountain View, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dielectrics, Inc. | Chicopee, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 15, 2025. 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.