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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
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Review Panel
Hematology
Review Panel
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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)
K
16
3318
Soules Intrauterine Insemination Catheter
2
Cleared 510(K)
K
16
2878
Kitazato ET Catheters
2
Cleared 510(K)
K
16
2667
Kitazato IUI Catheter
2
Cleared 510(K)
K
16
1547
Transem and EchoGen Embryo Transfer Catheters
2
Cleared 510(K)
K
16
2064
CrossBay IVF Embryo Transfer Catheter Set
2
Cleared 510(K)
K
14
3669
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
2
Cleared 510(K)
K
14
1666
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
2
Cleared 510(K)
K
13
1491
KITAZATO IUI CATHETER
2
Cleared 510(K)
K
11
2396
IUI CATHETERS
2
Cleared 510(K)
K
12
0154
INTRAUTERINE INSEMINATION (IUI) CATHETER
2
Cleared 510(K)
K
09
2579
INTRAUTERINE INSEMINATION (IUI) CATHETER
2
Cleared 510(K)
K
05
3208
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
2
Cleared 510(K)
K
05
2059
IUI CATHETER, MODEL 9057
2
Cleared 510(K)
K
05
0521
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
2
Cleared 510(K)
K
04
1470
MORTON IUI CATHETERS
2
Cleared 510(K)
K
03
3084
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
2
Cleared 510(K)
K
02
3382
COOPERSURGICAL MALLEABLE SYTLET
2
Cleared 510(K)
K
02
3383
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
2
Cleared 510(K)
K
02
3384
COOPERSURGICAL TRIAL TRANSFER CATHETER
2
Cleared 510(K)
K
02
3017
TUCKER EMBRYO CATHETER
2
Cleared 510(K)
K
02
3379
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
2
Cleared 510(K)
K
01
3536
EMTRAC; DELPHIN; SEMTRAC 2000 SET
2
Cleared 510(K)
K
01
3501
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
2
Cleared 510(K)
K
01
2220
TAO EMBRYO TRANSFER CATHETER SYSTEM
2
Cleared 510(K)
K
00
0950
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
2
Cleared 510(K)
K
00
0656
EMBRYON GIFT TRANSFER CATHETERS/SETS
2
Cleared 510(K)
K
99
4327
EMBRYON TRANSFER CATHETERS/SETS
2
Cleared 510(K)
K
99
2307
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
2
Cleared 510(K)
K
99
1266
<GENX> EMBRYO TRANSFER CATHETER CC GLIDER
2
Cleared 510(K)
K
99
0349
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
2
Cleared 510(K)
K
99
0350
WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
2
Cleared 510(K)
K
99
0348
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
2
Cleared 510(K)
K
98
3604
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
2
Cleared 510(K)
K
98
3595
TRANSMYOMETRIAL EMBRYO TRANSFER SET
2
Cleared 510(K)
K
98
3590
GIFT CATHETER SET/S
2
Cleared 510(K)
K
98
3591
INTRATUBAL TRANSFER SETS
2
Cleared 510(K)
K
98
3594
EMBRYO TRANSFER CATHETERS/SETS
2
Cleared 510(K)
K
98
3587
HYSTEROSCOPIC GIFT CATHETER SETS
2
Cleared 510(K)
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 26 May 2023 at 11:04 pm
OB
/
assisted-reproduction-devices
/
MQF
/
K052059
View Source
IUI CATHETER, MODEL 9057
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K052059
510(k) Type
Abbreviated
Applicant
INNTEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/22/2005
Days to Decision
116 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
K
16
3318
Soules Intrauterine Insemination Catheter
K
16
2878
Kitazato ET Catheters
K
16
2667
Kitazato IUI Catheter
K
16
1547
Transem and EchoGen Embryo Transfer Catheters
K
16
2064
CrossBay IVF Embryo Transfer Catheter Set
K
14
3669
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
K
14
1666
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
K
13
1491
KITAZATO IUI CATHETER
K
11
2396
IUI CATHETERS
K
12
0154
INTRAUTERINE INSEMINATION (IUI) CATHETER
K
09
2579
INTRAUTERINE INSEMINATION (IUI) CATHETER
K
05
3208
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
K
05
2059
IUI CATHETER, MODEL 9057
K
05
0521
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
K
04
1470
MORTON IUI CATHETERS
K
03
3084
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
K
02
3382
COOPERSURGICAL MALLEABLE SYTLET
K
02
3383
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
K
02
3384
COOPERSURGICAL TRIAL TRANSFER CATHETER
K
02
3017
TUCKER EMBRYO CATHETER
K
02
3379
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
K
01
3536
EMTRAC; DELPHIN; SEMTRAC 2000 SET
K
01
3501
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
K
01
2220
TAO EMBRYO TRANSFER CATHETER SYSTEM
K
00
0950
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
K
00
0656
EMBRYON GIFT TRANSFER CATHETERS/SETS
K
99
4327
EMBRYON TRANSFER CATHETERS/SETS
K
99
2307
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
K
99
1266
<GENX> EMBRYO TRANSFER CATHETER CC GLIDER
K
99
0349
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
K
99
0350
WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
K
99
0348
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
K
98
3604
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
K
98
3595
TRANSMYOMETRIAL EMBRYO TRANSFER SET
K
98
3590
GIFT CATHETER SET/S
K
98
3591
INTRATUBAL TRANSFER SETS
K
98
3594
EMBRYO TRANSFER CATHETERS/SETS
K
98
3587
HYSTEROSCOPIC GIFT CATHETER SETS
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
/
K052059
View Source
IUI CATHETER, MODEL 9057
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K052059
510(k) Type
Abbreviated
Applicant
INNTEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/22/2005
Days to Decision
116 days
Submission Type
Summary