OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece— 510(k) K143492
Substantially EquivalentBien-Air Surgery SA
FDA 510(k) clearance K143492 for OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece, Substantially Equivalent on 2015-03-04. 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 K143492
K-number listed on FDA's recall record- Z-0178-2021 — 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 (ENT) surgery.
- Z-0179-2021 — 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 stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143492.
Data sourced from openFDA. This site is unofficial and independent of the FDA.