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510(k) K232040

Gynatrof by Tyros Biopharma, Inc. — Product Code NUC

K232040 is an FDA 510(k) premarket notification submitted by Tyros Biopharma, Inc. for the device "Gynatrof". The FDA issued a decision of Substantially Equivalent on March 1, 2024. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2024
Date Received
July 10, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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  • K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (June 9, 2026)
  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K254101 — Julva Velvé Water-Based Personal Lubricant (April 16, 2026)
  • K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito (April 1, 2026)
  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)
  • K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30 (December 15, 2025)
  • K250488 — Cerynë Intimate Care (December 12, 2025)

FDA data resources