Data / Medical devices / Switzerland / Bien-Air Surgery SA
Bien-Air Surgery SA: FDA-registered device maker in Le Noirmont Jura, Switzerland, 5 510(k) clearances
Bien-Air Surgery SA is registered with the FDA (registration 3003800209) in Le Noirmont Jura, Switzerland. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 2, 2022. 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
- 3003800209
- Address
- rue de l Ouest 2b, Le Noirmont Jura, Switzerland, 2340
- Owner or operator
- Bien-Air Surgery SA (10024150)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 8, 2008
- Registered through
- 2026
- Brand names listed
- 80K / RAPIDO / PM PERFO Cable, 80K/RAPIDO Cable, 80k Micromotor, AQUACARE, BASCH Cable, BASCH Micromotor, BASCH-1 Micromotor, Bur Cranial Spiral 10mm St and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Contract manufacturer | accessdata.fda.gov |
| Blade, Saw, Surgical, Cardiovascular | DWH | 1 | Contract manufacturer | accessdata.fda.gov |
| Bur, Ear, Nose And Throat | EQJ | 1 | Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | 2 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Microdebrider, Ent, High Speed, Single Use, Reprocessed | NLY | 1 | Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Motor, Drill, Electric | HBC | 2 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Saw, Electrically Powered | DWI | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Ent | MMO | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 2, 2022 | K221184 | ORiGO System | ERL | Substantially Equivalent | Bien-Air Surgery SA | accessdata.fda.gov |
| October 31, 2022 | K213697 | ORiGO System | HBC | Substantially Equivalent | Bien-Air Surgery SA | accessdata.fda.gov |
| June 22, 2018 | K173066 | OSSEODUO Shaver and Drill System | HBC | Substantially Equivalent | Bien-Air Surgery SA | accessdata.fda.gov |
| March 20, 2009 | K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | ERL | Substantially Equivalent | Bien-Air Surgery SA | accessdata.fda.gov |
| November 27, 1979 | K792159 | FISCH DRILL SYSTEM | ERL | Substantially Equivalent | Jedmed Instrument Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2020 | 86419 | Class II | Ongoing | Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones. | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- All makers of Blade, Saw, General & Plastic Surgery, Surgical
- All makers of Motor, Drill, Electric
- All makers of Drills, Burrs, Trephines & Accessories (Simple, Powered)
- All makers of Blade, Saw, Surgical, Cardiovascular
Updated November 2, 2022. 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.