CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
FDA 510(k) clearance K103128 · decided 2011-02-23
Clearance details
- K-number
- K103128
- Device name
- CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
- Applicant
- Cadwell Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-25
- Decision date
- 2011-02-23
- Days to decision
- 121 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
- Kennewick, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.