Teal Wand
FDA 510(k) clearance DEN240045 · decided 2025-05-09
Clearance details
- K-number
- DEN240045
- Device name
- Teal Wand
- Applicant
- Teal Health, Inc.
- Decision
- Unknown
- Date received
- 2024-08-27
- Decision date
- 2025-05-09
- Days to decision
- 255 days
- Clearance type
- Direct
- Product code
- SEP
- Device class
- 2
- Regulation number
- 866.2920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Onclarity™ Self-Collection Kit (K260184) | Becton, Dickinson and Company | 2026-04-02 |
Recalls involving this device
No recalls on record reference this clearance.