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Data / Medical devices / United States / Hollister, Inc.

Hollister, Inc.: FDA-registered device maker in Mount Juliet, TN, United States, 15 510(k) clearances

Hollister, Inc. is registered with the FDA (registration 2320961) in Mount Juliet, TN, United States. It lists 28 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 13, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hollister, Inc.
FDA registration number
2320961
FEI number
3003172243
Address
12011 Volunteer BLVD, Mount Juliet, TN, United States, 37122
Owner or operator
Hollister Inc. (1480288)
Roles
Repackager or relabeler
First device listed
July 21, 1992
Registered through
2026
Brand names listed
ADAPT, Adapt, Advance (KOD), Advance Plus (KOD), Advance Plus Kit, Advance Plus Pocket (KOD), AnchorFast, AnchorFast Guard and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Colostomy, DisposableEZS1Repackager or relabeleraccessdata.fda.gov
Bag, StomalGDS1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collecting, UreterostomyEXG1Repackager 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, LiquidKMF1Repackager or relabeleraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Repackager or relabeleraccessdata.fda.gov
BedpanFOB1Repackager or relabeleraccessdata.fda.gov
Catheter Care TrayOHR2Repackager or relabeleraccessdata.fda.gov
Catheter, IrrigationGBX1Repackager or relabeleraccessdata.fda.gov
Catheter, StraightEZD2Repackager or relabeleraccessdata.fda.gov
Catheter, UrethralGBM2Repackager or relabeleraccessdata.fda.gov
Catheter, UrologicalKOD2Repackager or relabeleraccessdata.fda.gov
Cement, Stomal Appliance, OstomyEZR1Repackager or relabeleraccessdata.fda.gov
Collector, OstomyEXB1Repackager or relabeleraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Repackager or relabeleraccessdata.fda.gov
Device, Paste-On For Incontinence, Non-SterileNOA1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Enema KitFCE1Repackager or relabeleraccessdata.fda.gov
Irrigator, OstomyEXD2Repackager or relabeleraccessdata.fda.gov
Ostomy Care KitPQE1Repackager or relabeleraccessdata.fda.gov
Protector, OstomyEXE1Repackager or relabeleraccessdata.fda.gov
Rod, ColostomyEZP2Repackager or relabeleraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Repackager or relabeleraccessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileNNZ1Repackager or relabeleraccessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, SterileEYZ1Repackager or relabeleraccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Repackager or relabeleraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Repackager 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 13, 2022K213575Female IC (Not Finalized)EZDSubstantially EquivalentHollister Incorporatedaccessdata.fda.gov
January 27, 2022K211436Intermittent Catheter (Not Finalized)GBMSubstantially EquivalentHollister Incorporatedaccessdata.fda.gov
December 13, 2019K193148VaPro Plus Pocket, VaPro PlusGBMSubstantially EquivalentHollister Incorporatedaccessdata.fda.gov
December 18, 2018K183253ValPro 2 Plus, VaPro 2 Plus PocketGBMSubstantially EquivalentHollister Incorporatedaccessdata.fda.gov
June 22, 2018K180824VaPro 2 Intermittent CatheterGBMSubstantially EquivalentHollister Incorporatedaccessdata.fda.gov
August 22, 2014K141642VAPRO INTERMITTENT CATHETERGBMSubstantially EquivalentHollister Incorporatedaccessdata.fda.gov
May 17, 2004K040779RESTORE WOUND CLEANSERKMFSubstantially EquivalentHollister, Inc.accessdata.fda.gov
January 9, 2004K032710CLOSED SYSTEM INTERMITTENT CATHETERIZATION KITKODSubstantially EquivalentApogee Medical, Inc.accessdata.fda.gov
January 14, 2002K013483INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KITKODSubstantially EquivalentHollister, Inc.accessdata.fda.gov
July 18, 2001K011552UROLOGICAL CATHETERGBMSubstantially EquivalentApogee Medical, Inc.accessdata.fda.gov
September 3, 1999K992137UROLOGICAL CATHETERGBMSubstantially EquivalentApogee, Inc.accessdata.fda.gov
August 18, 1995K953232HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICEKNTSubstantially EquivalentHollister, Inc.accessdata.fda.gov
October 13, 1993K932855HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICEKNTSubstantially EquivalentHollister, Inc.accessdata.fda.gov
October 17, 1989K893888HOLLISTER FEEDING TUBE ATTACHMENT DEVICEKNTSubstantially EquivalentHollister, Inc.accessdata.fda.gov
September 23, 1986K862573HOLLISTER DRAIN TUBE ATTACHMENTKNTSubstantially EquivalentHollister, Inc.accessdata.fda.gov

Compare with other makers

Updated September 13, 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.