Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003702646

FEI Number

3003702646

Entity Name

ETHICON SARL

City/State/Country

NEUCHATEL, CH

Establishment Address

PUITS GODET 20, NEUCHATEL 2000, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

TVT Reusable Catheter Guide (instruments code 810061) TVT EXACT Trocar TVT Reusable Introducer (Instrument code 810051) GYNECARE TVT ABBREVO Continence System GYNECARE TVT ABBREVO and GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide 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 TVT Abdominal Guides and Couplers TVT Reusable Introducer TVT Reusable Catheter Guide Gynecare TVT Exact Continence System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2018-07-19
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2012-01-26
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2018-08-20
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
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
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2013-09-10

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
3014272734	GMED Healthcare BVBA ( a Johnson & Johnson Company)	Courcelles Luxembourg, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222293	Urocure, LLC	ArcSP Suprapubic Sling System	2022-09-21

Similar Registrations

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3021632375	IVUS ILAC SANAYI VE TICARET AS	Istanbul, TR
3014272734	GMED Healthcare BVBA ( a Johnson & Johnson Company)	Courcelles Luxembourg, BE
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US
3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
3003990090	CALDERA MEDICAL, INC.	Westlake Village, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003702646. Last updated year: 2026. Please use registration number 3003702646 when referencing this establishment in official correspondence.