Clearance Summary
Teal Wand received FDA 510(k) clearance under submission number DEN240045, sponsored by Teal Health, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-05-09.
- Submission: DEN240045
- Applicant / Sponsor: Teal Health, Inc.
- Clearance pathway: Direct
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.2920
- Decision date: 2025-05-09
Classification & Regulation
This clearance is catalogued under FDA product code SEP and 21 CFR 866.2920, within the Microbiology review panel as a Class II device.