Global Fertilization, Embryo Culture and Transfer Media

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K053552 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• <genx> Single Lumen Sideport Needle

  Class II

  FDA 510(k) K991264 Active Cleared 9 Sep 1999

• Genxcatheter

  Class II

  FDA 510(k) K963031 Active Cleared 21 Oct 1996

• Global by <genx> Blastocyst Media

  Class II

  FDA 510(k) K010183 Active Cleared 2 May 2001

• Allgrad Wash (Herpes Buffered Washing Medium)

  Class II

  FDA 510(k) K023033 Active Cleared 26 Nov 2002

• Htf Plus - Htf with Non-Essential Amino Acids

  Class II

  FDA 510(k) K022334 Active Cleared 28 Aug 2002

• Genx Microtools

  Class II

  FDA 510(k) K993884 Active Cleared 14 Feb 2000

See all devices from <Genx> Intl., Inc. →

• What is the Global Fertilization, Embryo Culture, and Transfer Media used for?

  This medium is designed to provide a chemically defined environment for in vitro fertilization (IVF) processes. It supports the fertilization of human oocytes, embryo culture from Day 1 through Day 5, and preparation for embryo transfer. The formulation includes energy substrates and essential amino acids to optimize embryo growth and development in clinical laboratory settings.

• Is this medium sterile and single-use?

  The provided data does not explicitly state whether the Global Fertilization, Embryo Culture, and Transfer Media is sterile or single-use. However, its use in clinical IVF procedures is governed by regulatory standards for reproductive media (regulation number 884.6180), which typically require adherence to sterility and single-use protocols for patient safety. Always follow manufacturer guidelines and local regulatory requirements.

• How is this medium supplied, and where is it used?

  The Global Fertilization, Embryo Culture, and Transfer Media is supplied as a single-step, protein-free formulation. It is intended exclusively for use in clinical laboratory settings during IVF procedures, providing a controlled environment for fertilization, embryo development, and transfer preparation.

• What regulatory approval does this product hold?

  This device has received FDA 510(k) clearance with a determination of Substantially Equivalent (SESE) under the classification of a Class II medical device (K053552). The product was reviewed by the Obstetrics/Gynecology (OB) advisory committee and is intended for reproductive media applications as defined by regulation 884.6180.

• Are there different sizes or models of this medium?

  The provided data lists multiple registration numbers (e.g., 3018010054, 3030390242) associated with this product, which may correspond to different lot sizes, formulations, or packaging variants. For specific details on sizes or models, refer to the manufacturer’s documentation or contact <Genx> Intl., Inc. directly, as these variations are not explicitly described in the regulatory submission.