Data / Medical devices / France / Novatech S.A.
Novatech S.A.: FDA-registered device maker in LA CIOTAT CEDEX Bouches-du-Rhone, France, 4 510(k) clearances
Novatech S.A. is registered with the FDA (registration 9613846) in LA CIOTAT CEDEX Bouches-du-Rhone, France. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613846
- FEI number
- 3002807769
- Address
- 1058, Voie Antiope Zi Athelia 3, LA CIOTAT CEDEX Bouches-du-Rhone, France, 13705
- Owner or operator
- NOVATECH SA (9011747)
- Roles
- Manufacturer
- First device listed
- October 26, 1994
- Registered through
- 2026
- Brand names listed
- DUTAU Forceps, DUTAU NOVATECH, ROTEPS, SURVAC, TONN, TONN NOVATECH Stent Applicator, TRACHEOBRONXANE-DUMON STENTS, TRACHEOBRONXANE DUMON® and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Tracheal, Preformed/Molded | NWA | 2 | 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 |
|---|---|---|---|---|---|---|
| February 6, 2025 | K242324 | DUTAU-NOVATECH® | EOQ | Substantially Equivalent | Novatech SA | accessdata.fda.gov |
| October 29, 2024 | K243126 | TRACHEOBRONXANE DUMON® | NWA | Substantially Equivalent | Novatech SA | accessdata.fda.gov |
| March 13, 2017 | K170030 | NOVATECH TALCAIR | GCJ | Substantially Equivalent | Novatech SA | accessdata.fda.gov |
| August 21, 1997 | K971509 | ENDOXANE | NWA | Substantially Equivalent - Subject to Tracking Reg. | Novatech SA | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Tracheal, Preformed/Molded
- All makers of Instrument, Ent Manual Surgical
- All makers of Forceps, Ent
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Catheters, Suction, Tracheobronchial
Updated February 6, 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.