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Data / Medical devices / United States / Endure Industries, Inc.

Endure Industries, Inc.: FDA-registered device maker in Homer, NY, United States, 17 510(k) clearances

Endure Industries, Inc. is registered with the FDA (registration 3013187142) in Homer, NY, United States. It lists 41 device types. The FDA files 17 510(k) clearances under its listings, the newest dated September 12, 2023. Registered through 2026. 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 Endure Industries, Inc.
FDA registration number
3013187142
Address
45 North Fulton St, Homer, NY, United States, 13077
Owner or operator
Endure Industries, Inc. (10053392)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 26, 2018
Registered through
2026
Brand names listed
Adult Urine Leg Bag 1000ml, Non-Sterile, Anesthesia mask, Bacterial Viral Filter, Bandage Scissors, Breathing Filters, Butterfly Needles (With / without Needles), Chromic Catgut Sutures, Endure Catgut and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Repackager or relabeleraccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Repackager or relabeleraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Ear WickKCN1Specification developeraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Repackager or relabeleraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Repackager or relabeleraccessdata.fda.gov
Snare, SurgicalGAE1Repackager or relabeleraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Specification developeraccessdata.fda.gov
Staple, Removable (Skin)GDT1Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, SyntheticGAN2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorable, OphthalmicHMN3Repackager or relabeleraccessdata.fda.gov
Suture, NonabsorbableGAO2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyesterGAS2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Repackager or relabeleraccessdata.fda.gov
Syringe, AntistickMEG2Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Repackager or relabeleraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.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
September 12, 2023K213767Endure ETCO2/02 Nasal CannulaCCKSubstantially EquivalentEndure Industries, Inc.accessdata.fda.gov
February 13, 2019K181508U&U Blood Collection SetsFMISubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
January 28, 2019K183004WEGO-PGA RAPIDGAMSubstantially EquivalentFoosin Medical Supplies Inc., Ltd.accessdata.fda.gov
June 5, 2018K180661SIGMA Sterilization Pouch and RollFRGSubstantially EquivalentSigma Medical Supplies Corp.accessdata.fda.gov
December 11, 2017K170276Safety Blood Collection Device for Single UseFMISubstantially EquivalentGemtier Medical (Shanghai), Inc.accessdata.fda.gov
March 25, 2016K152808U&U Insulin Syringe with/without Safety Retractable DeviceMEGSubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
March 2, 2016K151024Finger Type Pulse OximeterDQASubstantially EquivalentTaidoc Technology Corporationaccessdata.fda.gov
December 18, 2015K151498Breathing circuit bacterial/viral filterCAHSubstantially EquivalentZhejiang Haisheng Medical Device Co., Ltd.accessdata.fda.gov
February 19, 2015K1424363S Safety Insulin SyringeMEGSubstantially EquivalentSincere Medical Device Co., Ltd.accessdata.fda.gov
July 30, 2014K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERCAHSubstantially EquivalentVr Medicalaccessdata.fda.gov
January 14, 2014K130737SYNTHETIC ABSORBABLE SUTUREGAMSubstantially EquivalentFoosin Medical Supplies Inc., Ltd.accessdata.fda.gov
January 14, 2014K130735SYNTHETIC ABSORBABLE SUTUREGAMSubstantially EquivalentFoosin Medical Supplies Inc., Ltd.accessdata.fda.gov
June 9, 2008K080684WG-SURGICAL SUTURES WITH NEEDLEGAPSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
April 30, 2008K073614WG-SURGICAL SUTURES WITH NEEDLENEWSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
September 20, 2004K032878KUNG SHIN, HMEF SK203CAHSubstantially EquivalentKung Shin Plastics Co., Ltd.accessdata.fda.gov
April 28, 2000K000542PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPGALSubstantially EquivalentArc Medical Supplies (Beijing) Co, Ltd.accessdata.fda.gov
June 2, 1999K982646AILEE SUTURES AND AILEE NEEDLESGALSubstantially EquivalentMyco Medical Supplies, Inc.accessdata.fda.gov

Compare with other makers

Updated September 12, 2023. 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.