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Data / Medical devices / United Kingdom / Gbuk Group Limited

Gbuk Group Limited: FDA-registered device maker in Selby North Yorkshire, United Kingdom, 8 510(k) clearances

Gbuk Group Limited is registered with the FDA (registration 3007441619) in Selby North Yorkshire, United Kingdom. It lists 24 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Gbuk Group Limited
FDA registration number
3007441619
Address
Woodland House, Blackwood Hall Business Park North Duffield, Selby North Yorkshire, United Kingdom, YO8 5DD
Owner or operator
GBUK Group Limited (10056284)
Roles
Exporter to the US, Specification developer
First device listed
November 24, 2017
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Aid, TransferIKX1Specification developeraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Exporter to the US, Specification developeraccessdata.fda.gov
Catheter, Conduction, AnestheticBSO2Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Exporter to the US, Specification developeraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Exporter to the US, Specification developeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Specification developeraccessdata.fda.gov
Enteral Specific Transition ConnectorsPIO2Specification developeraccessdata.fda.gov
Enteral Syringes With Enteral Specific ConnectorsPNR2Exporter to the US, Specification developeraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Specification developeraccessdata.fda.gov
Filter, Conduction, AnestheticBSN2Specification developeraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Specification developeraccessdata.fda.gov
Lift, Patient, Ac-PoweredFNG2Specification developeraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Exporter to the US, Specification developeraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Protector, OstomyEXE1Specification developeraccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Exporter to the USaccessdata.fda.gov
Sling, Overhead Suspension, WheelchairINE1Specification developeraccessdata.fda.gov
Syringe, AntistickMEG2Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the US, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Tubeless Analysis, Gastric AcidityJLL1Specification developeraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter to the US, Specification developeraccessdata.fda.gov
Utensil, EatingILC1Specification developeraccessdata.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 21, 2022K220165Enteral Transition AdaptorPIOSubstantially EquivalentGBUK Group, Ltd.accessdata.fda.gov
August 19, 2021K203633Enteral Extension SetsPIFSubstantially EquivalentGBUK Group, Ltd.accessdata.fda.gov
October 1, 2020K202357Nutricare Clear-ISOSAF Nasogastric Feeding TubePIFSubstantially EquivalentThree Circles Consulting Limitedaccessdata.fda.gov
September 6, 2019K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseMEGSubstantially EquivalentJiangsu Micsafe Medical Technology Co., Ltd.accessdata.fda.gov
August 6, 2019K190502ENFit Oral / Enteral SyringePNRSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
November 9, 2017K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + AccessoriesFMFSubstantially EquivalentIntervene Group, Ltd.accessdata.fda.gov
October 20, 2017K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip SyringePNRSubstantially EquivalentIntervene Group Limitedaccessdata.fda.gov
April 5, 2016K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEPIFSubstantially EquivalentGbuk Enteral Limitedaccessdata.fda.gov

Compare with other makers

Updated October 21, 2022. 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.