DEN240045
- 510(k) number
- DEN240045
- Device name
- Teal Wand
- Applicant
- Teal Health, Inc. CA · US
- Product code
- SEP — Device For Home Collection And Transport Of Vaginal
- Decision date
- 2025-05-09
- Date received
- 2024-08-27
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN240045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.