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Data / Medical devices / United Kingdom / ConvaTec Limited, GDC Building

ConvaTec Limited, GDC Building: FDA-registered device maker in Deeside Flintshire, United Kingdom, 51 510(k) clearances

ConvaTec Limited, GDC Building is registered with the FDA (registration 3008806809) in Deeside Flintshire, United Kingdom. It lists 68 device types. The FDA files 51 510(k) clearances under its listings, the newest dated August 5, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch ConvaTec Limited, GDC Building
FDA registration number
3008806809
Address
First Avenue Deeside Industrial Park, Deeside Flintshire, United Kingdom, CH5 2NU
Owner or operator
ConvaTec (2241599)
Roles
Specification developer
First device listed
June 1, 1981
Registered through
2026
Brand names listed
365-E (ADULT), 367-E (PEDIATRIC), ABVISER, ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive, ACTIVE LIFE One-Piece Closed-End Pouch, ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier, ACTIVE LIFE One-Piece Urostomy Pouch Durahesive, AQUACEL Ag and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Specification developeraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Specification developeraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Specification developeraccessdata.fda.gov
Appliance, Colostomy, DisposableEZS1Specification developeraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Specification developeraccessdata.fda.gov
Bag, ReservoirBTC1Specification developeraccessdata.fda.gov
Bag, Urinary, IleostomyEXH1Specification developeraccessdata.fda.gov
Bag, Urine Collecting, UreterostomyEXG1Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Specification developeraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Catheter Care TrayOHR2Specification developeraccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Specification developeraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Specification developeraccessdata.fda.gov
Catheter, StraightEZD2Specification developeraccessdata.fda.gov
Catheter, UrethralGBM2Specification developeraccessdata.fda.gov
Catheter, UrologicalKOD2Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Specification developeraccessdata.fda.gov
Cement, Stomal Appliance, OstomyEZR1Specification developeraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Specification developeraccessdata.fda.gov
Clamp, CannulaFKC1Specification developeraccessdata.fda.gov
Collector, OstomyEXB1Specification developeraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Specification developeraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Specification developeraccessdata.fda.gov
Connector, Airway (Extension)BZA1Specification developeraccessdata.fda.gov
Connector, CatheterGCD1Specification developeraccessdata.fda.gov
Device, Cystometric, HydraulicFEN2Specification developeraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Specification developeraccessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, DisposableFFG2Specification developeraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Specification developeraccessdata.fda.gov
Dressing, Wound, DrugFROUSpecification developeraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Specification developeraccessdata.fda.gov
ForcepsHTD1Specification developeraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Specification developeraccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Specification developeraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Specification developeraccessdata.fda.gov
Irrigator, OstomyEXD2Specification developeraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Specification developeraccessdata.fda.gov
Mask, OxygenBYG1Specification developeraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Specification developeraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Specification developeraccessdata.fda.gov
Mouthpiece, BreathingBYP1Specification developeraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Specification developeraccessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction PumpOMP2Specification developeraccessdata.fda.gov
Ostomy Care KitPQE1Specification developeraccessdata.fda.gov
Pouch, ColostomyEZQ1Specification developeraccessdata.fda.gov
Protector, OstomyEXE1Specification developeraccessdata.fda.gov
Rod, ColostomyEZP2Specification developeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Specification developeraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Specification developeraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Specification developeraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Specification developeraccessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileNNZ1Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Specification developeraccessdata.fda.gov
Tube Tracheostomy And Tube CuffJOH2Specification developeraccessdata.fda.gov
Tube, FeedingFPD2Specification developeraccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Specification developeraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Specification developeraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Specification developeraccessdata.fda.gov
Urinometer, MechanicalEXR2Specification developeraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Specification 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
August 5, 2026K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).EZDSubstantially EquivalentConvatecaccessdata.fda.gov
June 24, 2026K253263ConvaVAC™ Negative Pressure Wound Therapy SystemOMPSubstantially EquivalentConvatec Limited, Gdc Buildingaccessdata.fda.gov
April 1, 2026K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZDSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
July 1, 2025K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)EZDSubstantially EquivalentConvatecaccessdata.fda.gov
June 6, 2025K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CFCMUnknownConvatec Limitedaccessdata.fda.gov
March 28, 2025K243228Flexi-Seal AIR (with ENFit Connector)KNTSubstantially EquivalentConvatecaccessdata.fda.gov
January 25, 2024K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZDSubstantially EquivalentConvatecaccessdata.fda.gov
June 22, 2022K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBMSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
April 30, 2019K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNTSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
October 19, 2018K180205AVELLE Negative Pressure Wound Therapy SystemOMPSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
August 16, 2018K181206GentleCath Glide Intermittent Urinary CatheterGBMSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
July 20, 2018K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFROSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
November 21, 2017K172924GentleCath Intermittent Urinary CatheterKODSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
March 7, 2017K162906Flexi-Seal PROTECT Fecal Management SystemKNTSubstantially EquivalentConvatecaccessdata.fda.gov
September 20, 2016K161344GentleCath Glide Intermittent CatheterKODSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
January 21, 2016K152926AQUACEL Ag Surgical SP DressingFROSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
July 21, 2015K150350Flexi-Seal Signal Fecal Management SystemKNTSubstantially EquivalentConvatec, Ltd.accessdata.fda.gov
December 23, 2013K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDEZDSubstantially EquivalentCure Medical, LLCaccessdata.fda.gov
June 6, 2013K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFROSubstantially EquivalentConvatec, Inc.accessdata.fda.gov
July 25, 2012K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFROSubstantially EquivalentConvatec, Inc.accessdata.fda.gov
April 26, 2012K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNTSubstantially EquivalentConvatec, Inc.accessdata.fda.gov
April 20, 2012K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPASubstantially EquivalentUnomedical A/S Infusion Devicesaccessdata.fda.gov
August 1, 2011K110653CURE CATHETEREZDSubstantially EquivalentCure Medical, LLCaccessdata.fda.gov
December 16, 2009K091034AQUACEL AG SURGICALFROSubstantially EquivalentConvatecaccessdata.fda.gov
September 4, 2009K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FROSubstantially EquivalentConvatec, A Division of E.R. Squibb & Sons, LLCaccessdata.fda.gov
June 11, 2008K080881CURE CATHETER CLOSED SYSTEMKODSubstantially EquivalentCure Medical, LLCaccessdata.fda.gov
May 2, 2008K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFROSubstantially EquivalentConvatec, A Division of E.R. Squibb & Sons, LLCaccessdata.fda.gov
September 13, 2007K072539CURE CATHETEREZDSubstantially EquivalentCure Medical, LLCaccessdata.fda.gov
April 8, 2004K032734CONVATEC FECAL MANAGEMENT SYSTEMKNTSubstantially EquivalentConvatec, A Bristol-Myers Squibb Co.accessdata.fda.gov
September 16, 1998K973076EUROMEDICAL HAEMATURIA FOLEY CATHETEREZLSubstantially EquivalentUnomedical Sdn Bhdaccessdata.fda.gov
November 21, 1996K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEBTRSubstantially EquivalentUnomedical Sdn Bhdaccessdata.fda.gov
October 30, 1995K954752PEDIATRIC EUROPHYLIC FOLEY CATHETEREZLSubstantially EquivalentRegulatory & Marketing Services, Inc.accessdata.fda.gov
June 29, 1995K944007EUROPHILIC SLIPPERY COATED FOLEY CATHETEREZLSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
May 22, 1995K951697PEDIATRIC ENDOTRACHEAL TUBEBTRSubstantially EquivalentUnomedical Sdn Bhdaccessdata.fda.gov
May 22, 1995K951696ENDOTRACHEAL TUBEBTRSubstantially EquivalentUnomedical Sdn Bhdaccessdata.fda.gov
March 21, 1995K945806SILICATH ALL SILICONE FOLEY CATHETEREZLSubstantially EquivalentUnomedical Sdn Bhdaccessdata.fda.gov
December 27, 1994K945874EUROMEDICAL POLY TRACHEOTOMY TUBEJOHSubstantially EquivalentRegulatory & Marketing Services, Inc.accessdata.fda.gov
November 30, 1994K915750DISPOSABLE BACTERIAL BREATHNG FILTERCAHSubstantially EquivalentHospitak, Inc.accessdata.fda.gov
February 11, 1992K915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNULCCKSubstantially EquivalentHospitak, Inc.accessdata.fda.gov
December 21, 1990K896734FEEDING TUBEFPDSubstantially EquivalentUnoplast A/Saccessdata.fda.gov
November 5, 1990K896729NELATON-, FEMALE - OR TIEMANN CATHETERKODSubstantially EquivalentUnoplast A/Saccessdata.fda.gov
December 3, 1987K874517PHARMASEAL RUBBER URETHRAL CATHETERKODSubstantially EquivalentAmerican Pharmaseal Div. Ahscaccessdata.fda.gov
October 26, 1987K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATORBTMSubstantially EquivalentHospitak, Inc.accessdata.fda.gov
August 8, 1984K842395SUR-FIT NIGHT DRAINAGE CONTAINER SETKNXSubstantially EquivalentConvatec, A Division of E.R. Squibb & Sonsaccessdata.fda.gov
July 9, 1984K841544AMER. PHARMASEAL SILICONIZED LATEXKODSubstantially EquivalentAmerican Pharmaseal Div. Ahscaccessdata.fda.gov
August 26, 1983K832299VISI-FLOW IRRIGATOREXDSubstantially EquivalentConvatec, A Division of E.R. Squibb & Sonsaccessdata.fda.gov
June 16, 1981K811240SUR-FIT LOOP OSTOMY O.R. SETEXBSubstantially EquivalentE. R. Squibb & Sons, Inc.accessdata.fda.gov
June 2, 1981K811160SUR-FIT IRRIGATION SLEEVEEXDSubstantially EquivalentE. R. Squibb & Sons, Inc.accessdata.fda.gov
September 7, 1979K791536DISPOSABLE MEDICATION NEBULIZERCAFSubstantially EquivalentHospitak, Inc.accessdata.fda.gov
February 17, 1977K770256CATHETERS, SILICONE COATEDKODSubstantially EquivalentPharmaseal Div., Baxter Healthcare Corp.accessdata.fda.gov
August 13, 1976K760372HUMIDIFIER, DISPOSABLEBTTSubstantially EquivalentHospitekaccessdata.fda.gov

Compare with other makers

Updated August 5, 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.