Data / Medical devices / United States / Ethicon, Inc.
Ethicon, Inc.: FDA-registered device maker in San Angelo, TX, United States, 23 510(k) clearances and 1 PMA approval
Ethicon, Inc. is registered with the FDA (registration 1614993) in San Angelo, TX, United States. It lists 6 device types. The FDA files 23 510(k) clearances and 1 PMA approval under its listings, the newest dated May 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1614993
- Address
- 3348 Pulliam ST., San Angelo, TX, United States, 76905
- Owner or operator
- ETHICON INC. (2210968)
- Roles
- Manufacturer
- First device listed
- January 3, 1994
- Registered through
- 2026
- Brand names listed
- COATED VICRYL SUTURE, Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture, Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture, LAPRA-TY SUTURE CLIP, MONOCRYL (Dyed) Suture, MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED, MONOCRYL PLUS Antibacterial (Poliglecaprone 25) Suture, MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Implantable | FZP | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic | GAN | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2026 | K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 6, 2026 | K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 22, 2025 | K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 12, 2025 | K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 15, 2022 | K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 22, 2022 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 21, 2020 | K201996 | Monocryl Plus Antibacterial Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 6, 2020 | K201143 | VICRYL Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 25, 2020 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 18, 2019 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 22, 2019 | K191373 | VICRYL Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 27, 2019 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 10, 2019 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 28, 2018 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 28, 2014 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 14, 2006 | K061037 | PDS PLUS ANTIBACTERIAL SUTURE | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 29, 2005 | K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 22, 2003 | K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 18, 1996 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 28, 1996 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 24, 1993 | K931492 | LAPRA-TY* SUTURE CLIP | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 13, 1981 | K810428 | VICRYL | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 28, 1982 | N18331 | PDS SUTURE (DYED) | NEW | 27 | May 12, 1997 | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Clip, Implantable
- All makers of Suture, Absorbable, Synthetic
- All makers of Mesh, Surgical, Polymeric
- All makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Updated May 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.