Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003910212

FEI Number

3003910212

Entity Name

W. L. GORE & ASSOCIATES, INC.

City/State/Country

ELKTON, MD, US

Establishment Address

301 AIRPORT RD., ELKTON, MD 21921, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

W. L. GORE & ASSOCIATES, INC. (Owner Number: 9925013)

Owner / Operator Contact Address

1505 North Fourth Street, Flagstaff, AZ 86004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191773

PMA Number

N/A

All Registered Proprietary Names

GORE-TEX® SUTURE GORE ® SYNECOR Intraperitoneal Biomaterial GORE-TEX Soft Tissue Patch GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement (Configured for Endoscopic Staplers) GORE ® VIABIL ® Short Wire Biliary Endoprosthesis GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement (Configured for Circular Staplers) GORE® BIO-A® Flex Intraperitoneal Tissue Reinforcement GORE® ENFORM INTRAPERITONEAL Biomaterial GORE® ENFORM PREPERITONEAL Biomaterial GORE® BIO-A® Flex Preperitoneal Tissue Reinforcement GORE® Tri-Lumen Catheter GORE® DUALMESH® Biomaterial GORE ® VIABIL ® Biliary Endoprosthesis GORE ® VIABIL ® Biliary Endoprosthesis GORE® BIO-A® Tissue Reinforcement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2006-09-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-02-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2007-12-18
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2006-09-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-05-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2007-12-18
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2023-02-10
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2023-02-10
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2023-02-10
OWZ	Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2023-02-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-10-23
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2007-12-18
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2011-02-09
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2007-12-18
OWZ	Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2019-08-01
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2019-08-01
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2019-08-01
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2019-08-01

Official Correspondent

Lisa Wells

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

W. L. GORE & ASSOCIATES, 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
3013164176	W. L. Gore & Associates, Inc.	Santa Clara, CA, US
3007284313	W. L. GORE & ASSOCIATES, INC.	Phoenix, AZ, US
2017233	W. L. GORE & ASSOCIATES, INC	FLAGSTAFF, AZ, US
3015138222	Gore European Warehouse Support	Tilburg Noord-Brabant, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003910212. Last updated year: 2026. Please use registration number 3003910212 when referencing this establishment in official correspondence.