510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MRXClass II

System, Assisted Reproduction Laser

21 CFR 884.6200 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

MRX is the FDA product code for System, Assisted Reproduction Laser, a class II device type, regulated under 21 CFR 884.6200. FDA's definition for this code reads: "This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved...". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MRX
Device name
System, Assisted Reproduction Laser
FDA definition
This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.
Regulation
21 CFR 884.6200
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
0

Clearances, product code MRX

By decision year
11 clearances under product code MRX with a decision year between 2004 and 2026, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MRX by decision year
YearClearances
20041
20051
20061
20072
20091
20121
20151
20201
20211
20261

Applicants with the most clearances

Product code MRX
Applicants holding the most 510(k) clearances under product code MRX
ApplicantClearances
Hamilton Thorne Biosciences3
Research Instruments Ltd3
HAMILTON THORNE, Inc.2
Hua Yue Medical Technology Co., Ltd.1
Minitube of America, Inc.1
Vitrolife Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code