ETHICON, INC.

FDA Device Registration & Listing · Raritan, NJ, US · Registration 3017102971

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
3017102971
FEI Number
3017102971
Entity Name
ETHICON, INC.
City/State/Country
Raritan, NJ, US
Establishment Address
1000 Route 202, Raritan, NJ 08869, 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
K170767
PMA Number
N/A

All Registered Proprietary Names

INTERCEED GYNECARE INTERCEED Absorbable Adhesion Barrier 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 Endoknot/Endoloop made with Coated Vicryl Endoknot/Endoloop made with PDS II Endoknot made with Ethibond Excel 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 ETHI-PACK Surgical Stainless Steel Suture Nonsterile PROLENE (Polypropylene) 3D Patch PDS Plus (Polydioxanone) Antibacterial Suture VISTASEAL™ Laparoscopic Dual Applicator (45 cm Flexible) VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid) PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture SECURESTRAP Open Absorbable Strap Fixation Device MERSILENE WHITE WOVEN Polyester Fiber Ligature MERSILENE Tape MERSILENE WHITE WOVEN Polyester Fiber Strip STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device ULTRAPRO Comfort Plug PROLENE Soft Polypropylene Mesh MONOCRYL™ Plus Antibacterial Suture BONE WAX VICRYL Mesh ULTRAPRO HERNIA SYSTEM Urinary Placement Catheter (UPC) PDS Plus Antibacterial Suture VICRYL RAPIDE VICRYL™ (Polyglactin 910) Mesh ETHI-PACK* PRE-CUT SUTURE PDS PLATES PDS Flexible Plates COATED VICRYL SUTURE ETHIBOND EXCEL VALVE LOOP SUTURE PROLENE Polypropylene Mesh PROLENE Hernia System Mersilene Tape MERSILENE WHITE WOVEN Polyester Fiber Strip MERSILENE WHITE WOVEN Polyester Fiber Ligature Nylon Tape PRONOVA Poly (Hexafluoropropylene - VDF) Suture VISTASEAL Dual Applicator DERMABOND PRINEO Skin Closure System (42mm) PROCEED SURGICAL MESH DERMABOND Prineo Skin Closure System (60mm) and DERMABOND Prineo Skin Closure System (22cm) ETHIZIA Hemostatic Patch PROLENE on TEFLON Pledget Suture Buttress Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture ETHICON SECURESTRAP Absorbable Strap Fixation Device MONOCRYL PLUS Antibacterial (Poliglecaprone 25) Suture PROLENE (Polypropylene) Hernia System STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device DERMABOND ProPen DERMABOND Mini Topical Skin Adhesive DERMABOND ADVANCED Topical Skin Adhesive DERMABOND™ PRINEO™ Skin Closure System (22cm) MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices LAPRA-TY SUTURE CLIP Cotton Umbilical Tape GYNEMESH Prolene Soft Mesh ULTRAPRO ADVANCED Mesh ULTRAPRO Mesh MONOCRYL (Dyed) Suture Ethicon PHYSIOMESH Open Flexible Composite Mesh BLAKE Silicone Drain J-VAC Drain Adapter BLAKE Cardio Connector STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device Modified Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture Artisyn Y-Shaped Mesh Surgical Stainless Steel Suture

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MCN Barrier, Absorbable, Adhesion Unknown Class 3 N/A 2008-04-24
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
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-12-15
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
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2013-08-28
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 2007-03-26
MZM Fibrin Sealant Preparation Device General Hospital Class 2 880.5860 2019-07-12
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2022-03-08
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2013-02-13
HDH Needle, Cerclage, Gynecological Obstetrics/Gynecology Class 1 884.4530 2016-07-21
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2022-11-30
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-06-12
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2017-10-16
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2021-01-06
MTJ Wax, Bone Unknown Class U N/A 2007-05-03
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-12-16
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-11-09
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2003-08-27
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2025-11-24
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2011-11-09
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2020-12-11
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
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2010-03-10
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2007-05-03
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2007-05-03
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-23
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1991-12-20
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2012-01-26
MZM Fibrin Sealant Preparation Device General Hospital Class 2 880.5860 2019-06-07
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 2012-01-26
OMD Cutaneous Tissue Adhesive With Mesh General, Plastic Surgery Class 2 878.4011 2016-06-01
SGV Agent, Absorbable Hemostatic, Collagen With Polymeric Additives General, Plastic Surgery Class 3 878.4490 2025-12-16
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2012-02-08
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2018-12-12
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2010-04-09
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 1994-01-03
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-01-26
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2020-06-04
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2015-10-22
OMD Cutaneous Tissue Adhesive With Mesh General, Plastic Surgery Class 2 878.4011 2021-12-15
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2008-03-20
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2026-06-02
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-07-02
FOD Device, Occlusion, Umbilical General Hospital Class 1 880.5950 2014-04-30
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2012-01-26
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-23
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
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-11-10
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-09-16
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2026-05-05
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2011-12-15
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2012-08-20
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2017-11-03

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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0014-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - 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 3017102971. Last updated year: 2026. Please use registration number 3017102971 when referencing this establishment in official correspondence.
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