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Data / Medical devices / United States / Diversatek Healthcare Inc

Diversatek Healthcare Inc: FDA-registered device maker in Milwaukee, WI, United States, 22 510(k) clearances

Diversatek Healthcare Inc is registered with the FDA (registration 2183446) in Milwaukee, WI, United States. It lists 26 device types. The FDA files 22 510(k) clearances under its listings, the newest dated October 16, 2023. 2 recall events name it as the recalling firm. 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 Diversatek Healthcare Inc
FDA registration number
2183446
Address
102 East Keefe Ave., Milwaukee, WI, United States, 53212
Owner or operator
DIVERSATEK HEALTHCARE INC (2183446)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
August 22, 1994
Registered through
2027
Brand names listed
Cleanflow, Medovations

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Contract manufacturer, Manufactureraccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Complaint file establishmentaccessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)CBC2Complaint file establishmentaccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Bougie, Esophageal, And Gastrointestinal, Gastro-UrologyFAT2Contract manufacturer, Manufactureraccessdata.fda.gov
Bronchoscope AccessoryKTI2Complaint file establishmentaccessdata.fda.gov
Catheter, Ventricular, General & Plastic SurgeryGBS1Contract manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Complaint file establishmentaccessdata.fda.gov
Dilator, EsophagealKNQ2Manufacturer, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishmentaccessdata.fda.gov
Endoscope Channel AccessoryODC2Complaint file establishmentaccessdata.fda.gov
Endoscopic Bite BlockMNK1Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Complaint file establishment, Specification developeraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Complaint file establishmentaccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Complaint file establishment, Specification developeraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Complaint file establishmentaccessdata.fda.gov
Insufflator, LaparoscopicHIF2Complaint file establishmentaccessdata.fda.gov
Pump, Air, Non-Manual, For EndoscopeFEQ2Specification developeraccessdata.fda.gov
Retractor, FiberopticFDG1Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Snare, FlexibleFDI2Complaint file establishmentaccessdata.fda.gov
Snare, Non-ElectricalFGX1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Transilluminator, Ac-PoweredHJM2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Tray, Biopsy, Without Biopsy InstrumentsFCH1Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Complaint file establishment, Manufactureraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Complaint file establishmentaccessdata.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
October 16, 2023K232118ANDORATE® Valve KitODCSubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
July 7, 2023K230932ANDORATE® Valve KitOCXSubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
May 11, 2023K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveKTISubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
April 3, 2023K222006Sclerotherapy & Endoscopic NeedlesFBKSubstantially EquivalentG-Flex Europe Sprlaccessdata.fda.gov
March 3, 2023K221713Polypectomy SnareFDISubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
November 8, 2022K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle TubingOCXSubstantially EquivalentDiversatek Healthcareaccessdata.fda.gov
March 3, 2022K211787HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
June 24, 2020K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveODCSubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
June 18, 2020K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorODCSubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
May 15, 2020K200479AquaPulse Auxiliary Water ConnectorOCXSubstantially EquivalentGa Health Company Limitedaccessdata.fda.gov
June 7, 2019K191231Andorate Auxiliary Water Connector, Andorate Valves SetODCSubstantially EquivalentSmartdata Suzhou Co., Ltd.accessdata.fda.gov
April 17, 2019K182998Andorate Auxiliary Water ConnectorOCXSubstantially EquivalentSmartdata Suzhou Co., Ltd.accessdata.fda.gov
July 6, 2018K181509Endorate Valve SetsOCXSubstantially EquivalentSmartdata Suzhou Co., Ltd.accessdata.fda.gov
May 21, 2018K172729Polypectomy SnareFDISubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
April 16, 2018K172727HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
March 10, 2015K142068BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILEOCXSubstantially EquivalentMedovations, Inc.accessdata.fda.gov
February 20, 2015K150024Bissinger Monopolar CablesGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
August 2, 2010K093079TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-UKNSSubstantially EquivalentHobbs Medical, Inc.accessdata.fda.gov
February 2, 1998K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)FATSubstantially EquivalentMedovations, Inc.accessdata.fda.gov
February 11, 1997K964561ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TAFDGSubstantially EquivalentBioenterics Corp.accessdata.fda.gov
December 5, 1994K924646OVER THE GUIDEWIRE DILATATION SYSTEMKNQSubstantially EquivalentMedovations, Inc.accessdata.fda.gov
October 13, 1992K922038CO2 INSUFFLATION TUBINGHIFSubstantially EquivalentSurgeon Surgical Instrumentation, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 18, 202698649Class IIOngoingDiversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.accessdata.fda.gov
October 29, 202190776Class IITerminatedDiversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.accessdata.fda.gov

Compare with other makers

Updated April 23, 2026. 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.