Data / Medical devices / Sweden / Novus Scientific AB
Novus Scientific AB: FDA-registered device maker in Uppsala, Sweden, 1 510(k) clearance
Novus Scientific AB is registered with the FDA (registration 3010187263) in Uppsala, Sweden. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010187263
- Address
- Virdings Alle 2, Uppsala, Sweden, 754 50
- Owner or operator
- Novus Scientific AB (10034484)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 17, 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, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Surgical Film | OOD | 2 | Complaint file establishment, Manufacturer | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 19, 2016 | 74801 | Class II | Terminated | TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 | Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Film
- All makers of Mesh, Surgical, Absorbable, Abdominal Hernia
- 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.