Gynatrof— 510(k) K232040

Substantially Equivalent

Tyros Biopharma, Inc.

FDA 510(k) clearance K232040 for Gynatrof, Substantially Equivalent on 2024-03-01. Applicant: Tyros Biopharma, Inc..

Clearance details

Applicant: Tyros Biopharma, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2023-07-10
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.