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Data / Medical devices / United States / Medivators Inc

Medivators Inc: FDA-registered device maker in Conroe, TX, United States, 26 510(k) clearances

Medivators Inc is registered with the FDA (registration 1651395) in Conroe, TX, United States. It lists 18 device types. The FDA files 26 510(k) clearances under its listings, the newest dated November 8, 2024. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Medivators Inc
FDA registration number
1651395
FEI number
3003012447
Address
3150 Pollok Drive, Conroe, TX, United States, 77303
Owner or operator
STERIS Corporation (2150060)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 9, 2008
Registered through
2027
Brand names listed
Adult Bite Block, AmplifEYE, DEFENDO Air/Water and Suction Valves (100305, 100306), DEFENDO Air/Water and Suction Valves (100305, 100311), DEFENDO Air/Water and Suction Valves (100306), DEFENDO Air/Water and Suction Valves (100317), DEFENDO Air/Water/Suction and Biopsy Valve (100316), DEFENDO Air/Water/Suction and Biopsy Valves and Kits (100301, 100305, 100310) and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessories, Cleaning, For EndoscopeFEB2Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Complaint file establishmentaccessdata.fda.gov
Bronchoscope AccessoryKTI2Repackager or relabeleraccessdata.fda.gov
Bulb, Inflation, For EndoscopeFCY1Complaint file establishment, Manufactureraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Manufacturer, Specification developeraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Repackager or relabeleraccessdata.fda.gov
Endoscope Channel AccessoryODC2Manufacturer, Specification developeraccessdata.fda.gov
Endoscope Introducer KitNWU2Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Complaint file establishmentaccessdata.fda.gov
Endoscopic Bite BlockMNK1Complaint file establishmentaccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Manufacturer, Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For EndoscopeFCX2Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Pump, Air, Non-Manual, For EndoscopeFEQ2Manufacturer, Specification developeraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 8, 2024K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)ODCSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
March 22, 2024K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use ConnectorODCSubstantially EquivalentMedivators (A Subsidiary of Steris Corporation)accessdata.fda.gov
March 6, 2024K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesODCSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
March 6, 2024K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use ConnectorODCSubstantially EquivalentMedivators (A Subsidiary of Steris Corporation)accessdata.fda.gov
December 21, 2023K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterODCSubstantially EquivalentMedivators (A Subsidiary of Steris Corporation)accessdata.fda.gov
August 14, 2023K231418ENDOGATOR™ Hybrid Irrigation TubingOCXSubstantially EquivalentMedivatorsaccessdata.fda.gov
May 11, 2023K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveKTISubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
March 1, 2023K223040Endo SmartCapFAJSubstantially EquivalentMedivators, Inc.accessdata.fda.gov
March 11, 2022K220395EndoGator Endoscopy Irrigation TubingFEQSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
January 14, 2022K213833SCOPE BUDDY PLUS Endoscope Flushing AidFEBSubstantially EquivalentMedivators, Inc.accessdata.fda.gov
December 21, 2016K162128Scope Buddy Plus Endoscope Flushing AidFEBSubstantially EquivalentMedivators, Inc.accessdata.fda.gov
July 14, 2016K160846AmplifEYEFEDSubstantially EquivalentMedivators, Inc.accessdata.fda.gov
June 20, 2012K113310ENDOGATER AVANTAGE CO2 INSUFFLATORFCXSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
April 27, 2012K113119ENDOGATOR ADVANTAGE IRRIGATION PUMPOCXSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
June 10, 2011K110088DEFENDO Y-OPSY IRRIGATORODCSubstantially EquivalentByrne Medical Incorporatedaccessdata.fda.gov
November 19, 2010K102855UNIVERSAL IRRIGATION SOLUTION HYBRIDOCXSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
November 8, 2010K102581DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305ODCSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
November 4, 2010K102409DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304ODCSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
February 22, 2010K093718ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003FCYSubstantially EquivalentZutron Medical, LLCaccessdata.fda.gov
December 15, 2009K093665ENDO SMARTCAPFAJSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
November 19, 2009K092429ENDOGATORFEQSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
July 2, 2009K090851DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)ODCSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
September 24, 2007K070432GENERAL SURGERY DRAPESKKXSubstantially EquivalentWelmed, Inc.accessdata.fda.gov
December 14, 2006K062969MEDLINE STERILE DISPOSABLE SURGICAL GOWNSFYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 19, 2006K060962ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100OCXSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
December 23, 2003K033695IRRIGATION CHANNEL TUBING, MODEL 100135OCXSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov

Compare with other makers

Updated November 8, 2024. 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.