FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K112083

Device Name

LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES

Manufacturer

<GENX> INTL., INC.

Date Cleared

2012-05-03

(287 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

LifeGlobal Global Total: Culture of human embryos from zygote to blastocyst, and embryo transfer LifeGlobal Global Total for Fertilization: Human oocyte culture and fertilization LifeGlobal Global Total w/HEPES: Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer

Device Description

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K Number

K080395

Device Name

SUNIVF DISHES

Manufacturer

<GENX> INTL., INC.

Date Cleared

2008-08-13

(182 days)

Product Code

MQK

Regulation Number

884.6160

Intended Use

The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation. The SunIVF Micromanipulation™ Dish is intended to be used to hold human sperm, oocytes and embryos during their manipulation in in vitro procedures of assisted human reproduction, including fertilization by intracytoplasmic sperm injection, assisted hatching, and biopsy. The SunIVF ICSI™ Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection. The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation. The SunIVF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation. The SunIVF Vitrification Dish is intended to be used to hold human oocytes and embryos during the procedures of vitrification. The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture. The SunIVF General Flat Dish – 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos. The SunIVF General Flat Dish – 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos. The SunIVF General Flat Dish – 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.

Device Description

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K Number

K053552

Device Name

GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA

Manufacturer

<GENX> INTL., INC.

Date Cleared

2006-05-19

(150 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

Device Description

global®: fertilization, embryo culture and transfer medium

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K Number

K053551

Device Name

MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL

Manufacturer

<GENX> INTL., INC.

Date Cleared

2006-05-09

(140 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

LG Paraffin Oil PG is designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching.

Device Description

Micromanipulation Media System: LG Hyaluronidase, LG Paraffin Oil

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K Number

K040530

Device Name

MEDIA CULTURE SYSTEM

Manufacturer

<GENX> INTL., INC.

Date Cleared

2004-06-25

(116 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction. global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction. PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis.

Device Description

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K Number

K023033

Device Name

ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)

Manufacturer

<GENX> INTL., INC.

Date Cleared

2002-11-26

(75 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

AllGrad Wash is used for sperm washing procedures such as in vitro washing and incubation of sperm in Assisted Reproduction techniques

Device Description

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K Number

K022590

Device Name

PVP (POLYVINYLPYRROLIDONE)

Manufacturer

<GENX> INTL., INC.

Date Cleared

2002-08-30

(25 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

Used to slow the motility of spermatozoa for the use in ICSI procedure.

Device Description

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K Number

K022334

Device Name

HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS

Manufacturer

<GENX> INTL., INC.

Date Cleared

2002-08-28

(41 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.

Device Description

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K Number

K022352

Device Name

HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)

Manufacturer

<GENX> INTL., INC.

Date Cleared

2002-08-28

(40 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

HTF Plus with HEPES (HTF with non-essential amino acids) is used as a holding media for human gametes and embryos for assisted reproduction.

Device Description

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K Number

K022547

Device Name

ACIDIFIED TYRODES SOLUTION

Manufacturer

<GENX> INTL., INC.

Date Cleared

2002-08-28

(27 days)

Product Code

MQL

Regulation Number

884.6180

Intended Use

To be used for the softening of the embryo zona during assisted reproductive procedures

Device Description

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