Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012085539

FEI Number

3012085539

Entity Name

SterCUBE Surgical Systems, LLC

City/State/Country

Grapevine, TX, US

Establishment Address

1452 Hughes Rd Ste 200, Pmb 550, Grapevine, TX 76051, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SteriCUBE Surgical Systems, LLC (Owner Number: 10050671)

Owner / Operator Contact Address

1452 Hughes Road, Suite 200, PMB #550, Grapevine, TX 76051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152014

PMA Number

N/A

All Registered Proprietary Names

MTS300 Transfer Cart, Steris, Standard GETINGE Bridge MTS300 Filter Kit STERIS Bridge MTS300 Transfer Cart, FL, Universal STERIS Evolution Bridge MTS225 Cabinet MTS225 GETINGE Cabinet MTS300 Cabinet, Steris, Standard MTS225 GETINGE Transfer Cart MTS225 TCFL Transfer Cart MTS225 Transfer Cart, Steris 600 MTS225 Cabinet, Steris 600 MTS300 Transfer Cart, Getinge MTS300 Cabinet, Steris, Evolution MTS Filter Kit MTS225 STERIS Transfer Cart MTS300 Transfer Cart, Steris, Evolution MTS300 Floor Loader, Getinge MTS300 Cabinet, Getinge SteriCUBE Filter Kit Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-12-14

Official Correspondent

Lisa Holt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SteriCUBE Surgical Systems, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

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1526531	STERIS Corporation	CLEVELAND, OH, US
3005706667	TURNER MEDICAL INC.	Athens, AL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012085539. Last updated year: 2026. Please use registration number 3012085539 when referencing this establishment in official correspondence.