Stivax
FDA 510(k) clearance K152571 · decided 2016-05-26
Clearance details
- K-number
- K152571
- Device name
- Stivax
- Applicant
- Biegler GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-09-09
- Decision date
- 2016-05-26
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- BWK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mauerbach, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.