GSI Corti
FDA 510(k) clearance K180287 · decided 2018-05-11
Clearance details
- K-number
- K180287
- Device name
- GSI Corti
- Applicant
- Grason-Stadler, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-02-01
- Decision date
- 2018-05-11
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- EWO
- Device class
- 2
- Regulation number
- 874.1050
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.