K-number	K242043
Device name	Sperm Freezing Medium
Applicant	Gimbo Medical Technology Shenzhen Co., Ltd.
Product code	MQL
Device class	Class II
Decision date	Jan 8, 2025
Decision	Substantially Equivalent
Regulation	884.6180

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Sperm Freezing Medium is a reproductive media device intended for cryopreservation of human semen samples to prevent damage during freezing and thawing prior to use in assisted reproductive technology (ART) procedures. It is classified as a Class II device under regulation 21 CFR 884.6180 (Reproductive Media and Supplements).

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence to legally marketed predicate devices but does not provide the specific technical comparison, testing methodology, or detailed reasoning used to establish equivalence.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Sperm Freezing Medium

Everything you need for a 510(k) submission. Nothing you don't.