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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
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Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
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General Hospital
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Hematology
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Immunology
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Microbiology
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Neurology
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Obstetrical and Gynecological
Review Panel
Assisted Reproduction Devices
CFR Sub-Part
MQE
Needle, Assisted Reproduction
2
Product Code
K
19
0590
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
2
Cleared 510(K)
Show All 30 Submissions
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 20 January 2023 at 11:05 pm
OB
/
assisted-reproduction-devices
/
MQE
/
K190590
View Source
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190590
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2019
Days to Decision
263 days
Submission Type
Statement
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
K
19
0590
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Show All 30 Submissions
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
assisted-reproduction-devices
/
MQE
/
K190590
View Source
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190590
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2019
Days to Decision
263 days
Submission Type
Statement