510(k) K143492 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
| Applicant | Bien-Air Surgery SA, Le Noirmont, CH |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Dec 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143492
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.