510(k) K222106
- Device
- Waypoint GPS
- Applicant
- Waypoint Orthopedics, Inc.
- 510(k) number
- K222106
- Product code
- QWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-12
- Date received
- 2022-07-18
- Regulation
- 874.1820
- Classification name
- Optical Neurosurgical Nerve Locator
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tiffini Wittwer
- Address
- 300 Applebrooke Dr. Malvern PA US 19355 19355
FDA Registration Numbers#
- 3027595873