Data / Medical devices / United States / Mesh Suture, Inc
Mesh Suture, Inc: FDA-registered device maker in Chicago, IL, United States, 1 510(k) clearance
Mesh Suture, Inc is registered with the FDA (registration 3025431509) in Chicago, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025431509
- Address
- 1444 N Astor St Ste 3, Chicago, IL, United States, 60610
- Owner or operator
- Mesh Suture, Inc. (10086760)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 8, 2022
- Registered through
- 2027
- Brand names listed
- Duramesh Mesh Suture
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 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 |
|---|---|---|---|---|---|---|
| September 2, 2022 | K211178 | DURAMESH Mesh Suture | GAW | Substantially Equivalent | Msi | accessdata.fda.gov |
Compare with other makers
Updated September 2, 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.