510(k) K083720 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
| Applicant | Bien-Air Surgery SA, Le Noirmont, CH |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Dec 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.