Data / Medical devices / Suture, Absorbable, Synthetic
Suture, Absorbable, Synthetic (GAN): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Suture, Absorbable, Synthetic (product code GAN, Class 2, 21 CFR 878.4830). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on December 15, 2000, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GAN
- Device class
- 2
- Regulation
- 878.4830
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Mexico | 2 |
| India | 1 |
| Peru | 1 |
Makers of Suture, Absorbable, Synthetic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | CIUDAD JUAREZ Chihuahua, Mexico | Manufacturer | 2 | December 18, 1996 | 0 | 1 | 0 | api.fda.gov |
| Ethicon, Inc. | San Angelo, TX, United States | Manufacturer | 2 | December 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 2 | December 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Specification developer | 2 | December 18, 1996 | 0 | 1 | 0 | api.fda.gov |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 2 | December 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | July 5, 1990 | 0 | 0 | 0 | api.fda.gov |
| Kollsut International Inc | North Miami Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meril Endo Surgery Pvt. Ltd. | Vapi Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Fibers OEM LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unilene, Sac | Lima Lima(Region), Peru | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 15, 2000. 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.