ETHICON, LLC.

FDA Device Registration & Listing · San Lorenzo, PR, US · Registration 2648650

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
2648650
FEI Number
2648650
Entity Name
ETHICON, LLC.
City/State/Country
San Lorenzo, PR, US
Establishment Address
Highway 183 Km. 8.3, San Lorenzo, PR 00754, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ETHICON INC. (Owner Number: 2210968)
Owner / Operator Contact Address
1000 US Highway 202 S., Raritan, NJ 08869, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PROLENE Polypropylene Mesh PROLENE Hernia System STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device DERMABOND Prineo Skin Closure System (60mm) and DERMABOND Prineo Skin Closure System (22cm) ETHILON Blue Suture DERMABOND PRINEO Skin Closure System (42mm) MERSILENE WHITE WOVEN Polyester Fiber Ligature MERSILENE Tape MERSILENE WHITE WOVEN Polyester Fiber Strip Temporary Cardiac Pacing Wire Surgical Stainless Steel Suture PRONOVA Poly (Hexafluoropropylene - VDF) Suture PERMA-HAND/Mersilk Suture/Silk Suture ETHILON Nylon Suture NUROLON ETHIBOND ETHIBOND EXCEL SURGICAL GUT SUTURE (Plain and Chromic) MERSILENE, MERSUTURE DERMABOND ProPen DERMABOND Mini Topical Skin Adhesive DERMABOND ADVANCED Topical Skin Adhesive STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices GYNEMESH Prolene Soft Mesh INTERCEED GYNECARE INTERCEED Absorbable Adhesion Barrier PROLENE Polypropylene Nonabsorbable Suture PROLENE Soft Polypropylene Mesh Mersilene Tape MERSILENE WHITE WOVEN Polyester Fiber Strip MERSILENE WHITE WOVEN Polyester Fiber Ligature Nylon Tape

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-23
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2020-06-04
OMD Cutaneous Tissue Adhesive With Mesh General, Plastic Surgery Class 2 878.4011 2016-06-01
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2019-03-18
OMD Cutaneous Tissue Adhesive With Mesh General, Plastic Surgery Class 2 878.4011 2017-05-02
HDH Needle, Cerclage, Gynecological Obstetrics/Gynecology Class 1 884.4530 2016-07-21
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2018-08-16
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2017-11-03
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2012-01-26
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-03-26
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2008-03-26
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2008-03-26
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2008-03-26
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2008-03-26
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2008-03-26
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2008-03-26
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2015-10-22
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2020-02-11
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2019-01-14
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2019-01-14
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2026-06-02
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2012-01-26
MCN Barrier, Absorbable, Adhesion Unknown Class 3 N/A 2008-04-24
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2013-12-11
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2017-10-16
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1991-12-20

Official Correspondent

Reynaldo Librojo

US Agent Details

No US Agent registered (Local establishment).

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
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18
K241486 Covidien Sofsilk™ Coated Braided Silk Suture 2024-12-03
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2009 Surgical Specialties Corp 2
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648650. Last updated year: 2026. Please use registration number 2648650 when referencing this establishment in official correspondence.
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