FDA Registration
Active
🇺🇸 United States
PGCL Sutures
Reg #: 3013187142
·
FEI: 3013187142
·
Expires 2025
Products
9
Proprietary Names
3
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ENDURE INDUSTRIES, INC.
- Registration Number
- 3013187142
- FEI Number
- 3013187142
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 45 North Fulton St
- City
- Homer
- State
- NY
- ZIP
- 13077
- Country
- US
Regulatory Submissions
- 510(k) Number
- K982646
Owner / Operator
- Firm Name
- Endure Industries, Inc.
- Operator Number
- 10053392
- Address
- 45 North Fulton St
- City
- Homer
- State
- NY
- Postal Code
- 13077
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Nonabsorable, Ophthalmic | HMN | Class 3 | Unknown | No | 2023-11-21 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Nonabsorbable | GAO | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2023-11-21 |
Proprietary Names
PGCL Sutures
Chromic Catgut Sutures
Plain Catgut Sutures
Establishment Types
Repack or Relabel Medical Device