# Bien-Air Surgery SA

- Location (FDA's records): Le Noirmont, CH
- FDA decisions: 5 (2009–2022): 5 510(k) clearances
- Product codes: ERL (3), HBC (2)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- The Anspach Effort, Inc.: 2 (https://510kreport.com/company/anspach-effort)
- Medtronic Xomed, Inc.: 2 (https://510kreport.com/company/medtronic-xomed)
- Gyrus Ent LLC: 1 (https://510kreport.com/company/gyrus-ent)

## Firms that cite its devices most
- Saeshin Precision Co., Ltd.: 2 (https://510kreport.com/company/saeshin-precision)
- Grace Medical, Inc.: 1 (https://510kreport.com/company/grace-medical)

## Its most-cited devices
- K173066: OSSEODUO Shaver and Drill System (2018), cited by 3
- K083720: Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K (2009), cited by 2
- K143492: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece (2015), cited by 2

## Recent decisions
- K221184: ORiGO System (Nov 2, 2022)
- K213697: ORiGO System (Oct 31, 2022)
- K173066: OSSEODUO Shaver and Drill System (Jun 22, 2018)
- K143492: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece (Mar 4, 2015)
- K083720: Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K (Mar 20, 2009)

Source page: https://510kreport.com/company/bien-air-surgery