Data / Medical devices / France / Askorn Medical
Askorn Medical: FDA-registered device maker in Cesson Sevigne Bretagne, France, 1 510(k) clearance
Askorn Medical is registered with the FDA (registration 3008880500) in Cesson Sevigne Bretagne, France. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008880500
- Address
- 44c rue de Bray, Cesson Sevigne Bretagne, France, F-35510
- Owner or operator
- Askorn Medical (10044425)
- Roles
- Exporter to the US, Specification developer
- First device listed
- June 10, 2013
- Registered through
- 2027
- Brand names listed
- BE POD MEDIO/AR PIED POIGNEE DROITE MINI AO, Cannulated Compressor PFCC, Chirobloc 3, Chirobloc Ballast, Chirobloc Large, Chirobloc Ring, Chirobloc Small, Chirobloc Wrist and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Tendon, Passive | HXA | 2 | Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 10, 2025 | K243477 | Universal Tendon Spacer | HXA | Substantially Equivalent | Askorn Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Screwdriver, Surgical
- All makers of Support, Patient Position
- All makers of Retractor
- All makers of Prosthesis, Tendon, Passive
Updated January 10, 2025. 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.