FDA Registration
Active
🇺🇸 United States
ETHICON, INC.
Reg #: 1614993
·
FEI: 1614993
·
Expires 2026
Products
6
Proprietary Names
31
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ETHICON, INC.
- Registration Number
- 1614993
- FEI Number
- 1614993
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3348 PULLIAM ST.
- City
- SAN ANGELO
- State
- TX
- ZIP
- 76905
- Country
- US
Regulatory Submissions
- 510(k) Number
- K253852
- PMA Number
- N18331
Owner / Operator
- Firm Name
- ETHICON INC.
- Operator Number
- 2210968
- Address
- 1000 US Highway 202 S.
- City
- Raritan
- State
- NJ
- Postal Code
- 08869
- Country
- US
- Correspondent
- Reynaldo Librojo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2026-03-09 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2022-03-08 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2008-03-20 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2020-12-11 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2008-08-06 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2007-07-02 |
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
STRATAFIX Spiral MONOCRYL Plus Unidirectional Knotless Tissue Control Device
MONOCRYL PLUS Antibacterial (Poliglecaprone 25) Suture
Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture
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
Establishment Types
Manufacture Medical Device