SinuBand
FDA 510(k) clearance K160101 · decided 2016-07-27
Clearance details
- K-number
- K160101
- Device name
- SinuBand
- Applicant
- Bioinspire Technologies, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2016-01-19
- Decision date
- 2016-07-27
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- QJL
- Device class
- 1
- Regulation number
- 874.4780
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.