Data / Medical devices / United States / Novus Scientific Inc
Novus Scientific Inc: FDA-registered device maker in Wrentham, MA, United States, 1 510(k) clearance
Novus Scientific Inc is registered with the FDA (registration 3009514842) in Wrentham, MA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009514842
- Address
- 190 Industrial Road Suite 2, Wrentham, MA, United States, 02093
- Owner or operator
- Novus Scientific (10046437)
- Roles
- Complaint file establishment
- First device listed
- February 25, 2021
- Registered through
- 2026
- Brand names listed
- TIGR Matrix Surgical Mesh
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | 2 | Complaint file establishment | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Complaint file establishment | accessdata.fda.gov |
| Surgical Film | OOD | 2 | Complaint file establishment | 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 26, 2020 | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | OWT | Substantially Equivalent | Novus Scientific AB | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Abdominal Hernia
- All makers of Surgical Film
- All makers of Mesh, Surgical, Polymeric
Updated March 26, 2020. 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.