Data / Medical devices / France / AB Medica SAS
AB Medica SAS: FDA-registered device maker in Mery Sur Cher Centre-Val de Loire, France, 3 510(k) clearances
AB Medica SAS is registered with the FDA (registration 3011221476) in Mery Sur Cher Centre-Val de Loire, France. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011221476
- Address
- Les Petites Quarterees, Mery Sur Cher Centre-Val de Loire, France, 18100
- Owner or operator
- ab Medica SAS (10047343)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 12, 2014
- Registered through
- 2026
- Brand names listed
- AbMedica Laparoscopic Hand Instrument and Trocar, Laparoscope, Pneumo Dissector Handle, Pneumo Dissector Hook, SCALPEL ACCESSORY TOOL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | 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 |
|---|---|---|---|---|---|---|
| January 23, 2026 | K252957 | Pneumo Dissector Hook | GCJ | Substantially Equivalent | Ab Medica Sas | accessdata.fda.gov |
| July 10, 2014 | K140101 | ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS | GCJ | Substantially Equivalent | Ab Medica Sas | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Scalpel, One-Piece
Updated January 23, 2026. 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.