ETHICON, INC.

FDA Device Registration & Listing · Somerville, NJ, US · Registration 2210968

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
2210968
FEI Number
2210968
Entity Name
ETHICON, INC.
City/State/Country
Somerville, NJ, US
Establishment Address
ROUTE 22 WEST, P.O. Box 151, Somerville, NJ 08876, 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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P880047

All Registered Proprietary Names

COATED VICRYL SUTURE VICRYL Mesh MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED ULTRAPRO ADVANCED Mesh ULTRAPRO Mesh SURGICEL Fibrillar Absorbable Hemostat SURGICEL Nu-Knit Absorbable Hemostat SURGICEL Absorbable Hemostat SURGICEL Powder Absorbable Hemostatic Powder SURGICEL Endoscopic Applicator SURGICEL Snow Absorbable Hemostat SECURESTRAP Open Absorbable Strap Fixation Device VICRYL Woven Mesh (Polyglactin 910) VICRYL Knitted Mesh(Polyglactin 910) Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture Artisyn Y-Shaped Mesh Temporary Cardiac Pacing Wire Modified Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture PROCEED SURGICAL MESH Endoknot/Endoloop made with Coated Vicryl Endoknot/Endoloop made with PDS II Endoknot made with Ethibond Excel PDS PLATES PDS Flexible Plates VISTASEAL™ Laparoscopic Dual Applicator (45 cm Flexible) VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid) STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device ETHICON ENDOSUTURE System DERMABOND ProPen DERMABOND Mini Topical Skin Adhesive DERMABOND ADVANCED Topical Skin Adhesive ULTRAPRO Comfort Plug 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 LAPRA-TY SUTURE CLIP Mersilene Tape MERSILENE WHITE WOVEN Polyester Fiber Strip MERSILENE WHITE WOVEN Polyester Fiber Ligature Nylon Tape J-VAC Suction Reservoir J-VAC Bulb Suction Reservoir PDS Plus (Polydioxanone) Antibacterial Suture Cotton Umbilical Tape PROLENE (Polypropylene) 3D Patch STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device DERMABOND Prineo Skin Closure System (60mm) and DERMABOND Prineo Skin Closure System (22cm) 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 PROLENE Soft Polypropylene Mesh ETHI-PACK* PRE-CUT SUTURE Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture DERMABOND™ PRINEO™ Skin Closure System (22cm) MERSILENE WHITE WOVEN Polyester Fiber Ligature MERSILENE Tape MERSILENE WHITE WOVEN Polyester Fiber Strip PROLENE (Polypropylene) Hernia System MONOCRYL™ Plus Antibacterial Suture MONOCRYL (Dyed) Suture PROLENE Polypropylene Nonabsorbable Suture PERMA-HAND/Mersilk Suture/Silk Suture ETHILON Nylon Suture NUROLON ETHIBOND ETHIBOND EXCEL SURGICAL GUT SUTURE (Plain and Chromic) MERSILENE, MERSUTURE DERMABOND PRINEO Skin Closure System (42mm) VICRYL™ (Polyglactin 910) Mesh PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture ULTRAPRO HERNIA SYSTEM GYNEMESH Prolene Soft Mesh ENDOSCOPIC APPLICATOR VICRYL RAPIDE BLAKE Silicone Drain J-VAC Drain Adapter BLAKE Cardio Connector PROLENE Polypropylene Mesh PROLENE Hernia System INTERCEED GYNECARE INTERCEED Absorbable Adhesion Barrier

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2007-05-03
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-12-16
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2008-03-20
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-23
LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery Class 3 878.4490 2011-09-27
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2013-02-13
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-03-06
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2018-12-12
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2012-08-20
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2018-08-16
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2011-12-15
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-01-26
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-12-15
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2010-03-10
MZM Fibrin Sealant Preparation Device General Hospital Class 2 880.5860 2019-07-12
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2020-02-11
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2012-08-17
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2012-08-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-08-17
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2015-10-22
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-06-12
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
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-07-02
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1991-12-20
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2011-07-07
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2007-03-26
FOD Device, Occlusion, Umbilical General Hospital Class 1 880.5950 2014-04-30
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-07-10
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
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
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2017-10-16
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2007-05-03
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2007-05-03
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2007-05-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2007-05-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2015-05-19
OMD Cutaneous Tissue Adhesive With Mesh General, Plastic Surgery Class 2 878.4011 2021-12-15
HDH Needle, Cerclage, Gynecological Obstetrics/Gynecology Class 1 884.4530 2016-07-21
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-01-26
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2021-01-06
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2008-03-20
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2008-03-20
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2013-12-11
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
OMD Cutaneous Tissue Adhesive With Mesh General, Plastic Surgery Class 2 878.4011 2017-05-02
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2020-12-11
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2022-03-08
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-11-09
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2012-01-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-12-22
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2011-11-09
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-09-16
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-23
MCN Barrier, Absorbable, Adhesion Unknown Class 3 N/A 2008-04-24

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
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2009 Ethicon, Inc. US 2
VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 The product is used for Soft Tissue approximation.
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 2210968. Last updated year: 2026. Please use registration number 2210968 when referencing this establishment in official correspondence.
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