Data / Medical devices / United States / SterCUBE Surgical Systems, LLC
SterCUBE Surgical Systems, LLC: FDA-registered device maker in Grapevine, TX, United States, 1 510(k) clearance
SterCUBE Surgical Systems, LLC is registered with the FDA (registration 3012085539) in Grapevine, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012085539
- Address
- 1452 Hughes Rd Ste 200 Pmb 550, Grapevine, TX, United States, 76051
- Owner or operator
- SteriCUBE Surgical Systems, LLC (10050671)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 14, 2015
- Registered through
- 2026
- Brand names listed
- GETINGE Bridge, MTS Filter Kit, MTS225 Cabinet, MTS225 Cabinet, Steris 600, MTS225 GETINGE Cabinet, MTS225 GETINGE Transfer Cart, MTS225 STERIS Transfer Cart, MTS225 TCFL Transfer Cart and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 20, 2015 | K152014 | MTS300 Multiple Tray Sterilization System | KCT | Substantially Equivalent | Pmbs, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 13, 2016 | 73157 | Class II | Terminated | The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit) | Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility. | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2015. 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.