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Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
HER
Pelvimeter, External
1
Product Code
FHG
Bell, Circumcision
2
Product Code
FHJ
Shield, Circumcision
2
Product Code
HCY
Curette, Uterine
1
Product Code
HCZ
Forceps, Surgical, Gynecological
2
Product Code
HDA
Forceps, Obstetrical
2
Product Code
HDB
Extractor, Vacuum, Fetal
2
Product Code
HDC
Tenaculum, Uterine
2
Product Code
HDD
Table, Obstetrical, Ac-Powered (And Accessories)
2
Product Code
HDE
Hook, Fibroid, Gynecological
1
Product Code
HDF
Speculum, Vaginal, Metal
1
Product Code
HDG
Speculum, Vaginal, Metal, Fiberoptic
1
Product Code
HDH
Needle, Cerclage, Gynecological
1
Product Code
HDI
Hook, Destructive, Obstetrical
2
Product Code
HDJ
Scissors, Umbilical
1
Product Code
HDK
Scissors, Episiotomy
1
Product Code
HDL
Retractor, Vaginal
1
Product Code
HDM
Packer, Uterine
1
Product Code
HDN
Dilator, Cervical, Expandable
3
Product Code
HDP
Elevator, Uterine
2
Product Code
HDQ
Dilator, Cervical, Fixed Size
1
Product Code
HDY
Dilator, Cervical, Hygroscopic-Laminaria
2
Product Code
HDZ
Knife, Cervical Cone
2
Product Code
HFB
Forceps, Biopsy, Gynecological
1
Product Code
HFG
Coagulator, Laparoscopic, Unipolar (And Accessories)
2
Product Code
HFH
Coagulator, Hysteroscopic (And Accessories)
2
Product Code
HFI
Coagulator, Culdoscopic (And Accessories)
2
Product Code
HFW
Clamp, Umbilical
2
Product Code
HFX
Clamp, Circumcision
2
Product Code
HFZ
Craniotribe
2
Product Code
HGA
Cranioclast
2
Product Code
HGC
Clamp, Uterine
1
Product Code
HGD
Applicator, Vaginal
1
Product Code
HGE
Amniotome
1
Product Code
HGI
Electrocautery, Gynecologic (And Accessories)
2
Product Code
HHF
Remover, Intrauterine Device, Contraceptive, Hook-Type
1
Product Code
HHG
Dilator, Cervical, Vibratory
3
Product Code
HHM
Sound, Uterine
1
Product Code
HHN
Cleidoclast
2
Product Code
HHO
Screw, Fibroid, Gynecological
2
Product Code
HHP
Table, Obstetrical, Manual (And Accessories)
2
Product Code
HHR
Laser, Surgical, Gynecologic
2
Product Code
HHT
Spatula, Cervical, Cytological
2
Product Code
HIB
Speculum, Vaginal, Nonmetal
2
Product Code
HIC
Speculum, Vaginal, Nonmetal, Fiberoptic
2
Product Code
HIM
Electrocautery, Endoscopic And Accessories
2
Product Code
HIN
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
2
Product Code
KNA
Instrument, Manual, Specialized Obstetric-Gynecologic
2
Product Code
KNB
Instrument, Destructive, Fetal, Obstetric
2
Product Code
KNC
Table, Obstetric (And Accessories)
2
Product Code
KNF
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
2
Product Code
KOH
Instrument, Manual, General Obstetric-Gynecologic
1
Product Code
LBX
Pelvimeter, Internal
2
Product Code
LKF
Cannula, Manipulator/Injector, Uterine
2
Product Code
K
24
2002
FemVue MINI Saline-Air Device
2
Cleared 510(K)
K
24
0364
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
2
Cleared 510(K)
K
24
1693
FemChec Controlled Saline-Air Device (FCD-250)
2
Cleared 510(K)
K
22
2798
Rejoni Intrauterine Catheter
2
Cleared 510(K)
K
22
3064
ALLY II Uterine Positioning System™ (UPS)
2
Cleared 510(K)
K
22
0202
Uterine ElevatOR PRO with OccludOR Balloon
2
Cleared 510(K)
K
21
2505
DUMI ManipulatOR
2
Cleared 510(K)
K
18
1770
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
2
Cleared 510(K)
K
18
0300
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
2
Cleared 510(K)
K
18
0291
Cook Silicone Balloon HSG Catheter
2
Cleared 510(K)
Show All 85 Submissions
LLW
Laser, Neodymium:Yag For Gynecologic Use
2
Product Code
MDG
System, Intrafallopian Cannula
2
Product Code
MLS
Labor And Delivery Kit
2
Product Code
MLT
Pelvic Exam Kit
2
Product Code
MOV
Catheters, Salpingography
2
Product Code
MPU
Source, Chemiluminescent Light
2
Product Code
NBZ
Clamp And Cutter, Umbilical
2
Product Code
NMG
Forceps, Biopsy, Gynecological, Reprocessed
2
Product Code
OHC
Obstetrical Vacuum Delivery Kit
2
Product Code
PBQ
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
2
Product Code
OHG
Circumcision Tray
2
Product Code
PFJ
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
2
Product Code
OHL
Pap Smear Kit
2
Product Code
OJF
Hysterectomy Kit
2
Product Code
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
2
Product Code
PKN
Dilator, Cervical, Synthetic, Osmotic
2
Product Code
OKU
Emergency Obstetrical Kit
1
Product Code
OKV
Obstetrical Kit
2
Product Code
OKY
Cytology Kit
2
Product Code
OQY
Intrauterine Tamponade Balloon
2
Product Code
PMU
Containment System, Laparoscopic Power Morcellation, With Instrument Port
2
Product Code
PON
Catheter, Balloon, Dilation Of Cervical Canal
2
Product Code
PUA
Tenaculum, Uterine, Exempt
2
Product Code
PVR
D&C Tray
2
Product Code
PVX
Vaginal Examination Tray
2
Product Code
PWB
Fetal Head Elevator
2
Product Code
PWI
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
2
Product Code
PWK
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
2
Product Code
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Unknown
Review Panel
Last synced on 3 January 2025 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
LKF
/
K180291
View Source
Cook Silicone Balloon HSG Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180291
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/26/2018
Days to Decision
267 days
Submission Type
Summary