Nerve Capping Device
FDA 510(k) clearance K152684 · decided 2016-01-13
Clearance details
- K-number
- K152684
- Device name
- Nerve Capping Device
- Applicant
- Polyganics Innovations BV
- Decision
- Substantially Equivalent
- Date received
- 2015-09-18
- Decision date
- 2016-01-13
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- JXI
- Device class
- 2
- Regulation number
- 882.5275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Groningen, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.