K232040
- 510(k) number
- K232040
- Device name
- Gynatrof
- Applicant
- Tyros Biopharma, Inc. CA
- Product code
- NUC — Lubricant, Personal
- Decision date
- 2024-03-01
- Date received
- 2023-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232040.pdf
Official FDA record: K232040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.