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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
K
20
0248
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
2
Cleared 510(K)
K
19
2540
Kitazato ET Catheters
2
Cleared 510(K)
K
19
0522
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination
2
Cleared 510(K)
K
19
1015
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
2
Cleared 510(K)
K
18
0302
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
2
Cleared 510(K)
K
17
3431
Towako Transmyometrial Embryo Transfer Set
2
Cleared 510(K)
K
17
3103
Pivet and Soft-Pass Embryo Transfer Catheter Sets
2
Cleared 510(K)
K
17
3686
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
2
Cleared 510(K)
K
17
2051
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
2
Cleared 510(K)
K
17
2321
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
2
Cleared 510(K)
Show All 48 Submissions
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
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
/
MQF
/
K172051
View Source
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172051
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/10/2018
Days to Decision
188 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
K
20
0248
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K
19
2540
Kitazato ET Catheters
K
19
0522
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination
K
19
1015
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
K
18
0302
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
K
17
3431
Towako Transmyometrial Embryo Transfer Set
K
17
3103
Pivet and Soft-Pass Embryo Transfer Catheter Sets
K
17
3686
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
K
17
2051
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K
17
2321
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
Show All 48 Submissions
MQG
Accessory, Assisted Reproduction
MQH
Microtools, Assisted Reproduction (Pipettes)
MQI
Microtool Fabrication, Assisted Reproduction
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
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
/
MQF
/
K172051
View Source
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172051
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/10/2018
Days to Decision
188 days
Submission Type
Summary