Bien-Air Surgery SA
Le Noirmont Jura, CH
BIEN-AIR SURGERY SA appears in FDA device records in Le Noirmont Jura, CH. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Bien-Air Surgery SA between 2009 and 2022. The busiest year on record is 2022, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221184 | ORiGO System | ERL | Substantially Equivalent | |
| K213697 | ORiGO System | HBC | Substantially Equivalent | |
| K173066 | OSSEODUO Shaver and Drill System | HBC | Substantially Equivalent | |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | ERL | Substantially Equivalent | |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | ERL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003800209 | 3003800209 | BIEN-AIR SURGERY SA | rue de l Ouest 2b, Le Noirmont Jura 2340 CH | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFABlade, Saw, General & Plastic Surgery, Surgical
- DWHBlade, Saw, Surgical, Cardiovascular
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- GBXCatheter, Irrigation
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed
- HBCMotor, Drill, Electric
- DWISaw, Electrically Powered
- MMOTray, Surgical, Ent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0180-2021 | Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology. | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Class II | Open, Classified | |
| Z-0179-2021 | Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs. | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Class II | Open, Classified | |
| Z-0178-2021 | Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery. | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Class II | Open, Classified | |
| Z-0177-2021 | Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium. | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Class II | Open, Classified | |
| Z-0176-2021 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain