Company ยท CH
Bien-Air Surgery SA
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2022. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 2022 | K221184 | ORiGO System Bien-Air Surgery SA, CH | ERL |
| Oct 31, 2022 | K213697 | ORiGO System Bien-Air Surgery SA, CH | HBC |
| Jun 22, 2018 | K173066 | OSSEODUO Shaver and Drill System Bien-Air Surgery SA, CH | HBC |
| Mar 4, 2015 | K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA, CH | ERL |
| Mar 20, 2009 | K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K Bien-Air Surgery SA, CH | ERL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2020 | Bien-Air Surgery Sa 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 a Open, Classified |
ERL | K083720 |
| Sep 11, 2020 | Bien-Air Surgery Sa 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 Open, Classified |
ERL | K143492 |
| Sep 11, 2020 | Bien-Air Surgery Sa 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 Open, Classified |
ERL | K143492 |
| Sep 11, 2020 | Bien-Air Surgery Sa 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 blade Open, Classified |
ERL | K083720 |
| Sep 11, 2020 | Bien-Air Surgery Sa 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. Open, Classified |
ERL | K792159 |