mi-eye 3 needlescope with cannula, mi-tablet 3
FDA 510(k) clearance K212556 · decided 2021-09-15
Clearance details
- K-number
- K212556
- Device name
- mi-eye 3 needlescope with cannula, mi-tablet 3
- Applicant
- Trice Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-13
- Decision date
- 2021-09-15
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.