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Review Panel
Hematology
Review Panel
Immunology
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Neurology
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Review Panel
Miscellaneous
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
K
04
1579
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
2
Cleared 510(K)
K
04
3614
VACULINK, MODEL VCL 3000
2
Cleared 510(K)
K
02
1193
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
2
Cleared 510(K)
K
02
0447
MITYVAC MERLIN, MODEL 10027
2
Cleared 510(K)
K
01
3460
SWIFT LOW PROFILE CUP (PRO CUP)
2
Cleared 510(K)
K
01
1532
MITYVAC
2
Cleared 510(K)
K
98
1260
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
2
Cleared 510(K)
K
98
0976
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
2
Cleared 510(K)
K
98
0212
MITYVAC
2
Cleared 510(K)
K
97
3942
SWIFT DELIVERY PRODUCT #300
2
Cleared 510(K)
K
97
0170
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
2
Cleared 510(K)
K
96
3287
VACUUM CUP (004SD)
2
Cleared 510(K)
K
96
0549
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
2
Cleared 510(K)
K
94
2725
CMI VELVET TOUCH VACUUM EXTRACTOR
2
Cleared 510(K)
K
94
3938
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
2
Cleared 510(K)
K
93
4011
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
2
Cleared 510(K)
K
91
3324
MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
2
Cleared 510(K)
K
91
5763
MODIFIED DISPOSABLE FETAL VACUUM
2
Cleared 510(K)
K
91
1326
OBSTETRICAL VACUUM CUP
2
Cleared 510(K)
K
89
5700
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
2
Cleared 510(K)
K
89
5446
CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
2
Cleared 510(K)
K
89
1465
OBSTETRIC CUP (MODIFICATION)
2
Cleared 510(K)
K
89
0307
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE
2
Cleared 510(K)
K
88
1967
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)
2
Cleared 510(K)
K
88
1306
CMI VACUUM DELIVERY SYSTEM #003C AND #004C
2
Cleared 510(K)
K
84
1492
AB VACUUM EXTRACTOR SILC-CUP
2
Cleared 510(K)
K
84
0008
O'NEIL OBSTETRIC CUP
2
Cleared 510(K)
K
83
0012
MEDELA SUCTION PUMP
2
Cleared 510(K)
K
77
1558
SILASTIC BRAND OBSTETRICAL VACUUM CUP
2
Cleared 510(K)
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
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 16 August 2024 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
HDB
/
K934011
View Source
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934011
510(k) Type
Traditional
Applicant
NEWARD ENTERPRISES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/1994
Days to Decision
260 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
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
HER
Pelvimeter, External
FHG
Bell, Circumcision
FHJ
Shield, Circumcision
HCY
Curette, Uterine
HCZ
Forceps, Surgical, Gynecological
HDA
Forceps, Obstetrical
HDB
Extractor, Vacuum, Fetal
K
04
1579
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K
04
3614
VACULINK, MODEL VCL 3000
K
02
1193
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
K
02
0447
MITYVAC MERLIN, MODEL 10027
K
01
3460
SWIFT LOW PROFILE CUP (PRO CUP)
K
01
1532
MITYVAC
K
98
1260
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
K
98
0976
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K
98
0212
MITYVAC
K
97
3942
SWIFT DELIVERY PRODUCT #300
K
97
0170
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
K
96
3287
VACUUM CUP (004SD)
K
96
0549
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
K
94
2725
CMI VELVET TOUCH VACUUM EXTRACTOR
K
94
3938
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
K
93
4011
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
K
91
3324
MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
K
91
5763
MODIFIED DISPOSABLE FETAL VACUUM
K
91
1326
OBSTETRICAL VACUUM CUP
K
89
5700
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K
89
5446
CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
K
89
1465
OBSTETRIC CUP (MODIFICATION)
K
89
0307
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE
K
88
1967
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)
K
88
1306
CMI VACUUM DELIVERY SYSTEM #003C AND #004C
K
84
1492
AB VACUUM EXTRACTOR SILC-CUP
K
84
0008
O'NEIL OBSTETRIC CUP
K
83
0012
MEDELA SUCTION PUMP
K
77
1558
SILASTIC BRAND OBSTETRICAL VACUUM CUP
HDC
Tenaculum, Uterine
HDD
Table, Obstetrical, Ac-Powered (And Accessories)
HDE
Hook, Fibroid, Gynecological
HDF
Speculum, Vaginal, Metal
HDG
Speculum, Vaginal, Metal, Fiberoptic
HDH
Needle, Cerclage, Gynecological
HDI
Hook, Destructive, Obstetrical
HDJ
Scissors, Umbilical
HDK
Scissors, Episiotomy
HDL
Retractor, Vaginal
HDM
Packer, Uterine
HDN
Dilator, Cervical, Expandable
HDP
Elevator, Uterine
HDQ
Dilator, Cervical, Fixed Size
HDY
Dilator, Cervical, Hygroscopic-Laminaria
HDZ
Knife, Cervical Cone
HFB
Forceps, Biopsy, Gynecological
HFG
Coagulator, Laparoscopic, Unipolar (And Accessories)
HFH
Coagulator, Hysteroscopic (And Accessories)
HFI
Coagulator, Culdoscopic (And Accessories)
HFW
Clamp, Umbilical
HFX
Clamp, Circumcision
HFZ
Craniotribe
HGA
Cranioclast
HGC
Clamp, Uterine
HGD
Applicator, Vaginal
HGE
Amniotome
HGI
Electrocautery, Gynecologic (And Accessories)
HHF
Remover, Intrauterine Device, Contraceptive, Hook-Type
HHG
Dilator, Cervical, Vibratory
HHM
Sound, Uterine
HHN
Cleidoclast
HHO
Screw, Fibroid, Gynecological
HHP
Table, Obstetrical, Manual (And Accessories)
HHR
Laser, Surgical, Gynecologic
HHT
Spatula, Cervical, Cytological
HIB
Speculum, Vaginal, Nonmetal
HIC
Speculum, Vaginal, Nonmetal, Fiberoptic
HIM
Electrocautery, Endoscopic And Accessories
HIN
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
KNA
Instrument, Manual, Specialized Obstetric-Gynecologic
KNB
Instrument, Destructive, Fetal, Obstetric
KNC
Table, Obstetric (And Accessories)
KNF
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
KOH
Instrument, Manual, General Obstetric-Gynecologic
LBX
Pelvimeter, Internal
LKF
Cannula, Manipulator/Injector, Uterine
LLW
Laser, Neodymium:Yag For Gynecologic Use
MDG
System, Intrafallopian Cannula
MLS
Labor And Delivery Kit
MLT
Pelvic Exam Kit
MOV
Catheters, Salpingography
MPU
Source, Chemiluminescent Light
NBZ
Clamp And Cutter, Umbilical
NMG
Forceps, Biopsy, Gynecological, Reprocessed
OHC
Obstetrical Vacuum Delivery Kit
PBQ
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
OHG
Circumcision Tray
PFJ
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
OHL
Pap Smear Kit
OJF
Hysterectomy Kit
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
PKN
Dilator, Cervical, Synthetic, Osmotic
OKU
Emergency Obstetrical Kit
OKV
Obstetrical Kit
OKY
Cytology Kit
OQY
Intrauterine Tamponade Balloon
PMU
Containment System, Laparoscopic Power Morcellation, With Instrument Port
PON
Catheter, Balloon, Dilation Of Cervical Canal
PUA
Tenaculum, Uterine, Exempt
PVR
D&C Tray
PVX
Vaginal Examination Tray
PWB
Fetal Head Elevator
PWI
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
PWK
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
HDB
/
K934011
View Source
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934011
510(k) Type
Traditional
Applicant
NEWARD ENTERPRISES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/1994
Days to Decision
260 days
Submission Type
Statement