DEN240045 is an FDA 510(k) submission for the Teal Wand. This device is classified as a Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay (Class II - Special Controls, product code SEP).
Submitted by Teal Health, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2920. A Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Hpv Testing Is A Device Intended For Use By Lay Users In Home Settings Or Similar Environments For The Collection And Transportation Of Vaginal Specimens For Testing Using An Approved Hpv Molecular Assay With Which The Device Has Been Validated..
| 510(k) Number | DEN240045 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 27, 2024 |
| Decision Date | May 09, 2025 |
| Days to Decision | 255 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | SEP - Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2920 |
| Definition | A Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Hpv Testing Is A Device Intended For Use By Lay Users In Home Settings Or Similar Environments For The Collection And Transportation Of Vaginal Specimens For Testing Using An Approved Hpv Molecular Assay With Which The Device Has Been Validated. |