Clearance Summary
EndeavorRx received FDA 510(k) clearance under submission number K231337, sponsored by Akili Interactive Labs, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-12-13.
- Submission: K231337
- Applicant / Sponsor: Akili Interactive Labs, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 882.5803
- Decision date: 2023-12-13
Classification & Regulation
This clearance is catalogued under FDA product code QFT and 21 CFR 882.5803, within the Obstetrics/Gynecology review panel as a Class II device.