Data / Medical devices / United States / Antarma LLC
Antarma LLC: FDA-registered device maker in New York, NY, United States, 3 510(k) clearances
Antarma LLC is registered with the FDA (registration 3014117096) in New York, NY, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 31, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014117096
- Address
- 276 5th Ave Rm 704, New York, NY, United States, 10001
- Owner or operator
- Antarma LLC dba Golnit Sutures (10056317)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 28, 2017
- Registered through
- 2026
- Brand names listed
- Golnit Nylon Monofilament Suture, Golnit PTFE Suture, Golnit PTFE Sutures
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 31, 2022 | K212888 | Golnit Nylon Monofilament Suture | GAR | Substantially Equivalent | Antarma, LLC Dba Golnit Sutures | accessdata.fda.gov |
| September 4, 2019 | K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | NBY | Substantially Equivalent | Antarma, LLC Dba Golnit Sutures | accessdata.fda.gov |
| June 21, 2017 | K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | NBY | Substantially Equivalent | Antarma Dba Golnit Sutures | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated March 31, 2022. 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.