510(k) K213697
K213697 is an FDA 510(k) premarket notification submitted by Bien-Air Surgery SA for the device "ORiGO System". The FDA issued a decision of Substantially Equivalent on October 31, 2022. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Bien-Air Surgery SA has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2022
- Date Received
- November 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type