ETHICON, INC.

FDA Device Registration & Listing · SAN ANGELO, TX, US · Registration 1614993

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
1614993
FEI Number
1614993
Entity Name
ETHICON, INC.
City/State/Country
SAN ANGELO, TX, US
Establishment Address
3348 PULLIAM ST., SAN ANGELO, TX 76905, 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
K931492
PMA Number
N/A

All Registered Proprietary Names

MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture MONOCRYL (Dyed) Suture PDS II Suture VICRYL™ (Polyglactin 910) Mesh PDS Plus Antibacterial Suture Modified Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture TFE Polymer Pledgets STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices 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 MONOCRYL™ Plus Antibacterial Suture STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device COATED VICRYL SUTURE STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED PDS Plus (Polydioxanone) Antibacterial Suture VICRYL Woven Mesh (Polyglactin 910) VICRYL Knitted Mesh(Polyglactin 910) VICRYL Mesh LAPRA-TY SUTURE CLIP

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 2026-03-09
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2022-03-08
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2026-06-02
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2015-05-19
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
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2013-05-17
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 2025-11-24
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2011-12-15
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2008-08-06
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2026-06-02
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 2021-01-06
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2020-06-04
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2007-05-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2020-02-11
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 2007-03-26
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-03-06
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-12-16
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-07-02

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

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 1614993. Last updated year: 2026. Please use registration number 1614993 when referencing this establishment in official correspondence.
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