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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Assisted Reproduction Devices
CFR Sub-Part
MQE
Needle, Assisted Reproduction
2
Product Code
MQF
Catheter, Assisted Reproduction
2
Product Code
MQG
Accessory, Assisted Reproduction
2
Product Code
MQH
Microtools, Assisted Reproduction (Pipettes)
2
Product Code
MQI
Microtool Fabrication, Assisted Reproduction
2
Product Code
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
2
Product Code
K
14
2207
TransferMan 4m Micromanipulator
2
Cleared 510(K)
K
12
0877
MICROMANIPULATOR SET
2
Cleared 510(K)
K
11
3712
IM-11 PNEUMATIC MICROINJECTOR
2
Cleared 510(K)
K
01
1420
MM-87 MOTOR-DRIVE MANIPULATOR
2
Cleared 510(K)
K
01
0298
MN-4 COARSE MANIPULATOR
2
Cleared 510(K)
K
00
3300
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
2
Cleared 510(K)
K
00
3303
IM-5B MICROINJECTOR
2
Cleared 510(K)
K
00
3302
IM-5A INJECTOR
2
Cleared 510(K)
K
00
3304
IM-6 MICROINJECTOR
2
Cleared 510(K)
K
00
3142
MICROMANIPULATOR
2
Cleared 510(K)
K
00
3298
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
2
Cleared 510(K)
K
00
2850
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
2
Cleared 510(K)
K
00
2659
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
2
Cleared 510(K)
K
00
2658
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
2
Cleared 510(K)
K
00
2653
MMN-1 COARSE MANIPULATOR
2
Cleared 510(K)
K
00
2291
MOTOR-DRIVE MANIPULATOR MM-89
2
Cleared 510(K)
K
00
2293
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
2
Cleared 510(K)
K
00
1911
IM-9A MICROINJECTORS
2
Cleared 510(K)
K
00
1912
IM-9B MICROINJECTORS
2
Cleared 510(K)
K
00
1910
IM-9C MICROINJECTORS
2
Cleared 510(K)
K
00
1131
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
2
Cleared 510(K)
K
00
1130
3D MANUAL COARSE MANIPULATOR MN-188NE
2
Cleared 510(K)
K
99
3884
GENX MICROTOOLS
2
Cleared 510(K)
MQK
Labware, Assisted Reproduction
2
Product Code
MQL
Media, Reproductive
2
Product Code
MRX
System, Assisted Reproduction Laser
2
Product Code
MTW
System, Water, Reproduction, Assisted, And Purification
2
Product Code
MTX
Microscope And Microscope Accessories, Reproduction, Assisted
1
Product Code
NNB
Needle, Reproduction, Assisted, Reprocessed
2
Product Code
PBH
Embryo Image Assessment System, Assisted Reproduction
2
Product Code
OYO
Culture, Intravaginal, Assisted Reproduction
2
Product Code
PUB
Accessory, Assisted Reproduction, Exempt
2
Product Code
PUC
Microtools, Assisted Reproduction (Pipettes), Exempt
2
Product Code
PUD
Labware, Assisted Reproduction, Exempt
2
Product Code
QKH
Assisted Reproduction Laminar Flow Workstation
2
Product Code
QKI
Media, Reproductive, Exempt
2
Product Code
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Prosthetic Devices
CFR Sub-Part
Clinical Chemistry Test Systems
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Physical Medicine Prosthetic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
OB
/
assisted-reproduction-devices
/
MQJ
/
K993884
View Source
GENX MICROTOOLS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K993884
510(k) Type
Traditional
Applicant
<GENX> INTL., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/14/2000
Days to Decision
90 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Assisted Reproduction Devices
MQE
Needle, Assisted Reproduction
MQF
Catheter, Assisted Reproduction
MQG
Accessory, Assisted Reproduction
MQH
Microtools, Assisted Reproduction (Pipettes)
MQI
Microtool Fabrication, Assisted Reproduction
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
K
14
2207
TransferMan 4m Micromanipulator
K
12
0877
MICROMANIPULATOR SET
K
11
3712
IM-11 PNEUMATIC MICROINJECTOR
K
01
1420
MM-87 MOTOR-DRIVE MANIPULATOR
K
01
0298
MN-4 COARSE MANIPULATOR
K
00
3300
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K
00
3303
IM-5B MICROINJECTOR
K
00
3302
IM-5A INJECTOR
K
00
3304
IM-6 MICROINJECTOR
K
00
3142
MICROMANIPULATOR
K
00
3298
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
K
00
2850
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
K
00
2659
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
K
00
2658
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
K
00
2653
MMN-1 COARSE MANIPULATOR
K
00
2291
MOTOR-DRIVE MANIPULATOR MM-89
K
00
2293
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
K
00
1911
IM-9A MICROINJECTORS
K
00
1912
IM-9B MICROINJECTORS
K
00
1910
IM-9C MICROINJECTORS
K
00
1131
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
K
00
1130
3D MANUAL COARSE MANIPULATOR MN-188NE
K
99
3884
GENX MICROTOOLS
MQK
Labware, Assisted Reproduction
MQL
Media, Reproductive
MRX
System, Assisted Reproduction Laser
MTW
System, Water, Reproduction, Assisted, And Purification
MTX
Microscope And Microscope Accessories, Reproduction, Assisted
NNB
Needle, Reproduction, Assisted, Reprocessed
PBH
Embryo Image Assessment System, Assisted Reproduction
OYO
Culture, Intravaginal, Assisted Reproduction
PUB
Accessory, Assisted Reproduction, Exempt
PUC
Microtools, Assisted Reproduction (Pipettes), Exempt
PUD
Labware, Assisted Reproduction, Exempt
QKH
Assisted Reproduction Laminar Flow Workstation
QKI
Media, Reproductive, Exempt
Cardiovascular Monitoring Devices
Cardiovascular Prosthetic Devices
Clinical Chemistry Test Systems
Diagnostic Devices
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Monitoring Devices
Obstetrical and Gynecological Prosthetic Devices
Obstetrical and Gynecological Surgical Devices
Obstetrical and Gynecological Therapeutic Devices
Physical Medicine Prosthetic Devices
Prosthetic Devices
Therapeutic Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
assisted-reproduction-devices
/
MQJ
/
K993884
View Source
GENX MICROTOOLS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K993884
510(k) Type
Traditional
Applicant
<GENX> INTL., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/14/2000
Days to Decision
90 days
Submission Type
Summary