ORiGO System
by Bien-Air Surgery SA 2 variants
510(k) K213697
ORiGO System is a Class II device made by Bien-Air Surgery SA, cleared under FDA 510(k) K213697 on 31 Oct 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213697 | Date31 Oct 2022 | StatusActive |
Official records
- FDA 510(k) database K213697
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HBC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4360
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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