OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K— 510(k) K083720
Substantially EquivalentBien-Air Surgery SA
FDA 510(k) clearance K083720 for OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K, Substantially Equivalent on 2009-03-20. Applicant: Bien-Air Surgery SA. Device class: 2.
Clearance details
- Applicant
- Bien-Air Surgery SA
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Noirmont, CH
Recent devices under product code ERL
view allMore clearances from Bien-Air Surgery SA
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K083720
K-number listed on FDA's recall record- 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.
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.