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Gynatrof

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232040

by Tyros Biopharma, Inc.

Identifiers

510(k) Number
K232040 FDA 510(k)
FDA Product Code
NUC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Gynatrof is a personal lubricant device intended for use in obstetrics and gynecology. It is classified as a Class II medical device under FDA regulation 884.5300.

The device was cleared via the FDA 510(k) pathway (K232040) on March 1, 2024, as substantially equivalent to a predicate device. It is manufactured by Tyros Biopharma, Inc. in Laval, Quebec, Canada.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Our Products | Gynatrof, Gynalac, Uriexo & Gynacan, Home - TYROS BIOPHARMA, Contact Us Today | Gynatrof, Tyros Biopharma - Shop Gynatrof, Gynalac, Gynacan & Uriexo

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tyros Biopharma, Inc.

Sources (1)

  • FDA 510(k) K232040 24 fields · synced Sep 27, 2026