STIMULATION/DISSECTION INSTRUMENTS
FDA 510(k) clearance K112709 · decided 2012-02-09
Clearance details
- K-number
- K112709
- Device name
- STIMULATION/DISSECTION INSTRUMENTS
- Applicant
- Nu Vasive, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2011-09-19
- Decision date
- 2012-02-09
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.