Ocelot System
510(k) K122380
Ocelot System is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K122380 on 7 Nov 2012, active as of 11 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 | NumberK122380 | Date7 Nov 2012 | StatusActive |
Official records
- FDA 510(k) database K122380
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PDU
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K122380
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Ocelot III O200 | O200 / O200 | 00851354004189 | — | On the market |
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