HOLLISTER INCORPORATED

FDA Device Registration & Listing · LIBERTYVILLE, IL, US · Registration 1480288

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1480288
FEI Number
1480288
Entity Name
HOLLISTER INCORPORATED
City/State/Country
LIBERTYVILLE, IL, US
Establishment Address
2000 HOLLISTER DR., LIBERTYVILLE, IL 60048, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Hollister Inc. (Owner Number: 1480288)
Owner / Operator Contact Address
2000 HOLLISTER DR., --, Libertyville, IL 60048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K932855
PMA Number
N/A

All Registered Proprietary Names

Female Urinary Pouch Male Urinary Pouch VaPro Pocket VaPro Plus Pocket Latex-Free Extension Tubing Hollister Leg Bag Straps Extension Tubing with Connector Urinary Leg Bag Urinary Leg Bag Holsters Deluxe Urinary leg Bag Straps Infyna Chic Hollister Apogee Catheter Insertion Kit VaPro Pocket Plus Kit Conform 2 Impression - C Nova NovaLife 1 Dansac New Image HOLLISTER UROSTOMY BAGS Center Point Lock Karaya 5 Securi-T USA Nova 2 NovaLife Urostomy Bags Moderma Flex NovaLife 2 GX+ NovaLife 2 Invent First Choice Tandem NovaLife 1 GX+ Compact Premier New Image Hollister VaPro (Tiemann/Coude) VaPro Pocket (Tiemann/Coude) Hollister VaPro Plus VaPro Plus Pocket VaPro Pocket Hollister Apogee Plus InstantCath Protect LOOP OSTOMY BRIDGE Urinary Leg Bag BEDSIDE URINE COLLECTOR Hollister Vented Leg Bag VaPro Pocket (40cm/16 inch) VaPro Pocket (20cm/8 inch) HOLLISTER HOLLISTER STOMA BAGS HOLLISTER DRAINING WOUND MANAGEMENT STOMA BAGS Adapt Adapt Securi-T USA Restore Restore Apogee IC Securi-T USA TRE Dansac Hollister CeraPlus Nova 2 Premium Adapt NovaLife 1 GX+ Nova 1 HolliHesive NovaLife Invent NovaLife 2 GX+ NovaLife 2 Nova Karaya NovaLife 1 Hollister Onli (LCC) InstantCath Securi-T USA Adapt Hollister ADAPT PREMIUM Securi-T USA KARAYA Vertical Drain/Tube Attachment Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOA Device, Paste-On For Incontinence, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2006-09-27
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2020-01-16
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2006-09-27
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2022-09-14
FCE Enema Kit Gastroenterology, Urology Class 1 876.5210 2006-10-17
OHR Catheter Care Tray Gastroenterology, Urology Class 2 876.5130 2010-02-06
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 1992-07-21
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 1992-07-21
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2026-05-21
FOB Bedpan General Hospital Class 1 880.6730 2006-10-17
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-05-22
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2006-05-24
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2004-06-28
EZP Rod, Colostomy Gastroenterology, Urology Class 2 876.4270 2006-10-16
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 1995-04-19
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2018-11-27
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2015-01-14
GDS Bag, Stomal Gastroenterology, Urology Class 1 876.5900 1992-07-21
EZS Appliance, Colostomy, Disposable Gastroenterology, Urology Class 1 876.5900 2017-03-06
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2015-01-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2001-08-01
KMF Bandage, Liquid General Hospital Class 1 880.5090 2007-11-30
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2004-06-28
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2006-09-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2006-05-24
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2022-04-12
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2004-06-28
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2016-03-08
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2006-05-24
EZR Cement, Stomal Appliance, Ostomy Gastroenterology, Urology Class 1 876.5900 1992-07-21
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2006-05-24

Official Correspondent

Sofia Abreu Read

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hollister Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016675012 Hollister Lietuva UAB Kaunas district, LT
9616668 HOLLISTER ULC REHINS BALLINA Mayo, IE
1119193 HOLLISTER INCORPORATED STUARTS DRAFT, VA, US
2320961 HOLLISTER, INC. Mount Juliet, TN, US
3014404707 Hollister Services BV Roosendaal Noord-Brabant, NL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0010-2013 C.R. Bard, Inc., Urological Division 2
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1480288. Last updated year: 2026. Please use registration number 1480288 when referencing this establishment in official correspondence.
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