ORiGO System
by Bien-Air Surgery SA 2 variants
510(k) K221184
ORiGO System is a Class II device made by Bien-Air Surgery SA, cleared under FDA 510(k) K221184 on 2 Nov 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 | NumberK221184 | Date2 Nov 2022 | StatusActive |
Official records
- FDA 510(k) database K221184
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ERL
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4250
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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