Waypoint GPS
FDA 510(k) clearance K222106 · decided 2023-05-12
Clearance details
- K-number
- K222106
- Device name
- Waypoint GPS
- Applicant
- Waypoint Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-18
- Decision date
- 2023-05-12
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- QWP
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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.