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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)
K
17
2846
Uterine Manipulator
2
Cleared 510(K)
K
17
1604
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
2
Cleared 510(K)
K
16
3214
Unicare System, Unicare Manipulator
2
Cleared 510(K)
K
16
0217
uVue HSG/SHG Catheter
2
Cleared 510(K)
K
15
3092
Ally Uterine Positioning System
2
Cleared 510(K)
K
15
0519
ManipulatOR PRO, ManipulatOR
2
Cleared 510(K)
K
14
2545
SonoFlow Sonohysterography and Sonohysterosalpingography Device
2
Cleared 510(K)
K
14
3415
Air Bubble Based Infuser (ABBI)
2
Cleared 510(K)
K
14
2716
VCARE
2
Cleared 510(K)
K
14
2164
MANIPULATOR; MANIPULATOR PRO
2
Cleared 510(K)
K
14
1523
ALLY UPS
2
Cleared 510(K)
K
13
1781
CLEARVIEW TOTAL
2
Cleared 510(K)
K
13
0758
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
2
Cleared 510(K)
K
12
2820
VIKY UP
2
Cleared 510(K)
K
12
3258
THE ADVANCE CATHETER FOR HSG AND SIS
2
Cleared 510(K)
K
10
2898
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
2
Cleared 510(K)
K
11
0993
FEMCHEC PRESSURE MANAGEMET DEVICE
2
Cleared 510(K)
K
11
0288
FEMVUE SALINE-AIR DEVICE
2
Cleared 510(K)
K
09
2983
PANPAC HSG CATHETER SET
2
Cleared 510(K)
K
09
2969
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
2
Cleared 510(K)
K
10
0662
FEMVUE CORNUAL BALLOON CATHETER
2
Cleared 510(K)
K
09
2984
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
2
Cleared 510(K)
K
09
3556
VCARE DX
2
Cleared 510(K)
K
09
2980
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
2
Cleared 510(K)
K
08
3594
EZ HSG CATHETER.FOAMSEAL CATHETER
2
Cleared 510(K)
K
08
3690
FEMVUE(TM) CATHETER SYSTEM
2
Cleared 510(K)
K
07
1405
PROBE HOLDER SYSTEM
2
Cleared 510(K)
K
07
1907
VCARE RETRACTOR/ELEVATOR
2
Cleared 510(K)
K
06
3611
SALINE/ CONTRAST MEDIA INFUSION CATHETER
2
Cleared 510(K)
K
06
1679
WALLACE ARTIFICIAL INSEMINATION CATHETER
2
Cleared 510(K)
K
04
1062
INTRAUTERINE VENOGRAM NEEDLE SET
2
Cleared 510(K)
K
04
0238
SOFTSEAL HSG CATHETER
2
Cleared 510(K)
K
04
1094
HSG CATHETER SET
2
Cleared 510(K)
K
03
2835
H/S CATHETER SET
2
Cleared 510(K)
K
02
3051
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
2
Cleared 510(K)
K
02
2503
UTERINE INJECTOR
2
Cleared 510(K)
K
02
1272
SIB CATHETER, MODEL 61-7005
2
Cleared 510(K)
K
02
0954
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
2
Cleared 510(K)
K
02
0292
UTERINE INJECTOR
2
Cleared 510(K)
K
02
0951
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
2
Cleared 510(K)
K
01
3972
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
2
Cleared 510(K)
K
01
3491
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
2
Cleared 510(K)
K
01
3437
SF SH CATHETER, MODEL R65-945
2
Cleared 510(K)
K
01
0296
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
2
Cleared 510(K)
K
01
0056
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
2
Cleared 510(K)
K
00
0433
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
2
Cleared 510(K)
K
00
1115
ULTRA CATHETER SET
2
Cleared 510(K)
K
97
4357
UTERINE MANIPULATOR/INJECTOR
2
Cleared 510(K)
K
97
0492
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
2
Cleared 510(K)
K
96
1752
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
2
Cleared 510(K)
K
95
5446
CONMED VCARE RETRACTOR/ELEVATOR
2
Cleared 510(K)
K
95
5508
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
2
Cleared 510(K)
K
94
6220
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
2
Cleared 510(K)
K
95
3034
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
2
Cleared 510(K)
K
94
3494
HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY
2
Cleared 510(K)
K
93
1167
OVAMED FALLOPIAN OSTIAL ACCESS CATHETER
2
Cleared 510(K)
K
94
3448
LUMIN
2
Cleared 510(K)
K
93
1122
OVAMED HSG CATHETER
2
Cleared 510(K)
K
93
2394
BERNSTEIN(TM) UTERINE MANIPULATOR
2
Cleared 510(K)
K
94
1458
UTERINE MANIPULATOR/INJECTOR WITH SPRING
2
Cleared 510(K)
K
94
1457
UTERINE INJECTOR WITH SPRING
2
Cleared 510(K)
K
93
5023
GODAT UTERINE MANIPULATOR INJECTOR
2
Cleared 510(K)
K
93
3981
CERVICAL CATHETER
2
Cleared 510(K)
K
93
3723
CONCEPTUS UTERINE CATHETER
2
Cleared 510(K)
K
94
0681
CLEARVIEW UTERINE MANIPULATOR
2
Cleared 510(K)
K
93
0867
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
2
Cleared 510(K)
K
93
2115
ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI
2
Cleared 510(K)
K
93
1814
DMI UTERINE MOBILIZER/ELEVATOR/CANNULA
2
Cleared 510(K)
K
93
5434
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
2
Cleared 510(K)
K
93
2432
KRONNER REINFORCING STYLETTE
2
Cleared 510(K)
K
93
0038
CANNULA: KAHN, JARCO, CORSON AND RATCHET
2
Cleared 510(K)
K
91
1887
MAJOLI UTERINE MANIPULATOR/INJECTOR
2
Cleared 510(K)
K
90
4079
BARD UTERINE MANIPULATOR
2
Cleared 510(K)
K
90
2975
TWIN BALLOON INJECTOR
2
Cleared 510(K)
K
77
2230
CANNULA, PERFUSION, FALLOPIAN TUBE
2
Cleared 510(K)
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
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 3 January 2025 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
LKF
/
K974357
View Source
UTERINE MANIPULATOR/INJECTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974357
510(k) Type
Traditional
Applicant
CATHETER RESEARCH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/2/1998
Days to Decision
75 days
Submission Type
Statement