Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014272734

FEI Number

3014272734

Entity Name

GMED Healthcare BVBA ( a Johnson & Johnson Company)

City/State/Country

Courcelles Luxembourg, BE

Establishment Address

European Distribution Centre, Rue du Luxembourg 5, Courcelles Luxembourg 6180, BE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ETHICON INC. (Owner Number: 2210968)

Owner / Operator Contact Address

1000 US Highway 202 S., Raritan, NJ 08869, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180910

PMA Number

N/A

All Registered Proprietary Names

EES - ECHELON ENDOPATH Staple Line Reinforcement TVT Abdominal Guides and Couplers TVT Reusable Introducer TVT Reusable Catheter Guide BI-MENTUM PE Liner BI-MENTUM Plus Cup BI-MENTUM Revision Cup BI-MENTUM Cemented Cup BI-MENTUM PressFit Cup BI-MENTUM Screw STERRAD 100NX STERILIZER GYNECARE TVT ABBREVO and GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide ECHELON ENDOPATH Staple Line Reinforcement GYNECARE TVT Obturator STERRAD NX STERILIZER ULTRAPRO PLUG ETHIZIA Hemostatic Patch Confidence Mapping Module GYNECARE TVT EXACT Continence System and Trocar GYNECARE TVT Introducer and Catheter Guide GYNECARE TVT System GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide GYNECARE TVT Obturator System and Passers and Winged Guide GYNECARE TVT with Abdominal Guides System PDS II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture VICRYL (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture Gynecare TVT Exact Continence System PROCEED VENTRAL PATCH SURGIFLO Hemostatic Matrix Kit SOUNDSTAR ECO SMS 8F CATHETER SOUNDSTAR ECO GE 8F CATHETER ULTRAPRO HERNIA SYSTEM SOUNDSTAR eco SMS 10F Catheter SOUNDSTAR ECO GE 10F CATHETER STERRAD 100S STERILIZER PREFACE Braided Guiding Sheath TVT Reusable Catheter Guide (instruments code 810061) TVT EXACT Trocar TVT Reusable Introducer (Instrument code 810051) Ethicon PHYSIOMESH Open Flexible Composite Mesh Artisyn Y-Shaped Mesh ACUNAV G 8F-90 CATHETER AcuNav 10F-90 Catheter ACUNAV 8F-90 ACUNAV G 10F-90 CATHETER GYNECARE TVT ABBREVO Continence System ULTRAPRO ADVANCED Mesh ULTRAPRO Mesh

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2026-01-16
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2018-07-17
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2018-07-17
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2019-05-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-05-07
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2019-02-05
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2018-08-20
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2020-03-04
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2012-01-26
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2019-02-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2011-11-09
SGV	Agent, Absorbable Hemostatic, Collagen With Polymeric Additives	General, Plastic Surgery	Class 3	878.4490	2025-12-16
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2019-03-03
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2020-12-11
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2020-12-11
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-01-02
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2020-01-02
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2013-09-10
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2011-11-09
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2019-01-31
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2019-03-03
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2011-11-09
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2019-03-03
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2019-02-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-03-19
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2018-07-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2014-11-10
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2012-08-20
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2019-03-03
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2012-01-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-07-23

Official Correspondent

Reynaldo Librojo

US Agent Details

Reynaldo Librojo Business: ETHICON Inc Email: rlibrojo@its.jnj.com Phone: (908) 8086028

Related Public Records

Same Entity

ETHICON 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
3023251262	GATT Technologies BV	Nijmegen Gelderland, NL
3004903580	Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda	SAO JOSE DOS CAMPOS Sao Paulo, BR
3013644499	JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA	Guarulhos Sao Paulo, BR
3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3003702646	ETHICON SARL	NEUCHATEL, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222293	Urocure, LLC	ArcSP Suprapubic Sling System	2022-09-21
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2014	Advanced Sterilization Products	2	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014	Advanced Sterilization Products	2	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.

Similar Registrations

Registration Number	Establishment Name	Location
3012481535	Teleflex Medical Inc.	Cincinnati, OH, US
3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3027419979	GUNZE MEDICAL LIMITED	Osaka, JP
3009380063	Medtronic Distribution Center	Memphis, TN, US
3011137372	Teleflex Medical LLC	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014272734. Last updated year: 2026. Please use registration number 3014272734 when referencing this establishment in official correspondence.