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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
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
2
Product Code
HET
Laparoscope, Gynecologic (And Accessories)
2
Product Code
HEW
Culdoscope (And Accessories)
2
Product Code
HEX
Colposcope (And Colpomicroscope)
2
Product Code
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
2
Product Code
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
F
Product Code
HFC
Aspirator, Endocervical
2
Product Code
HFD
Washer, Endometrial
2
Product Code
HFE
Brush, Endometrial
2
Product Code
HFF
Aspirator, Endometrial
2
Product Code
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
2
Product Code
HGW
Sampler, Blood, Fetal
2
Product Code
HHK
Curette, Suction, Endometrial (And Accessories)
2
Product Code
HIF
Insufflator, Laparoscopic
2
Product Code
HIG
Insufflator, Hysteroscopic
2
Product Code
HIH
Hysteroscope (And Accessories)
2
Product Code
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
1
Product Code
K
96
0203
G.E. STERILE AMNIOCENTESIS TRAY
1
Cleared 510(K)
K
95
5679
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
1
Cleared 510(K)
K
91
4419
AMNIOTEST(TM)
1
Cleared 510(K)
K
92
2960
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
1
Cleared 510(K)
K
92
1738
SONO-VU US(TM), MODIFICATION
1
Cleared 510(K)
K
91
5863
MEGA AMNIOCENTESIS KIT
1
Cleared 510(K)
K
90
4583
SONO-VU US(TM)
1
Cleared 510(K)
K
90
1643
ISOFLO(TM) AMNIOCENTESIS TRAY
1
Cleared 510(K)
K
90
0021
PERCU-SET(TM)
1
Cleared 510(K)
K
89
6031
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
1
Cleared 510(K)
K
89
4031
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
1
Cleared 510(K)
K
89
2846
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
1
Cleared 510(K)
K
89
0463
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
1
Cleared 510(K)
K
86
2365
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
1
Cleared 510(K)
K
85
4725
HURWITZ AMNIOCENTESIS NEEDLE
1
Cleared 510(K)
K
85
0632
PMS AMNIOCENTESIS TRAY/KIT
1
Cleared 510(K)
K
84
4558
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
1
Cleared 510(K)
K
83
0019
AMNIO CENTESES KIT W/NEEDLE
1
Cleared 510(K)
K
80
2666
APTEK ULTRASOUND PROCEDURE TRAY
1
Cleared 510(K)
K
76
1230
AMMOCENTESIS TRAY (KIT)
1
Cleared 510(K)
LHZ
Viscometer, Mucus, Cervical
1
Product Code
MKO
Falloposcope
2
Product Code
MOK
Vaginoscope And Accessories
2
Product Code
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
1
Product Code
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
2
Product Code
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
1
Product Code
NVT
Tubing And Tubing/Filter Fits
1
Product Code
NWV
Laparoscopic Accessories, Gynecologic
1
Product Code
NWW
Hysteroscope Accessories
1
Product Code
PCF
Sampler, Endocervical
2
Product Code
OHD
Gynecological Laparoscopic Kit
2
Product Code
OHE
Forensic Evidence Sexual Assault Kit
2
Product Code
OHF
Culdocentesis Kit
2
Product Code
OHM
Cesarean Section Tray
2
Product Code
OKX
Trocar Kit
2
Product Code
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
2
Product Code
OKZ
Endometrial Sampling Kit
2
Product Code
OSV
Insufflator, Endoscopic Vessel Harvesting
2
Product Code
PTZ
Colposcope (And Colpomicroscope), Exempt
2
Product Code
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
2
Product Code
QHZ
Seal, Cervical, Mechanical, Unpowered
1
Product Code
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
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-b—obstetrical-and-gynecological-diagnostic-devices
/
HIO
/
K844558
View Source
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844558
510(k) Type
Traditional
Applicant
UNIVERSAL MEDICAL INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/31/1985
Days to Decision
71 days
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
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
HET
Laparoscope, Gynecologic (And Accessories)
HEW
Culdoscope (And Accessories)
HEX
Colposcope (And Colpomicroscope)
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
HFC
Aspirator, Endocervical
HFD
Washer, Endometrial
HFE
Brush, Endometrial
HFF
Aspirator, Endometrial
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
HGW
Sampler, Blood, Fetal
HHK
Curette, Suction, Endometrial (And Accessories)
HIF
Insufflator, Laparoscopic
HIG
Insufflator, Hysteroscopic
HIH
Hysteroscope (And Accessories)
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
K
96
0203
G.E. STERILE AMNIOCENTESIS TRAY
K
95
5679
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
K
91
4419
AMNIOTEST(TM)
K
92
2960
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
K
92
1738
SONO-VU US(TM), MODIFICATION
K
91
5863
MEGA AMNIOCENTESIS KIT
K
90
4583
SONO-VU US(TM)
K
90
1643
ISOFLO(TM) AMNIOCENTESIS TRAY
K
90
0021
PERCU-SET(TM)
K
89
6031
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K
89
4031
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K
89
2846
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K
89
0463
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
K
86
2365
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
K
85
4725
HURWITZ AMNIOCENTESIS NEEDLE
K
85
0632
PMS AMNIOCENTESIS TRAY/KIT
K
84
4558
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K
83
0019
AMNIO CENTESES KIT W/NEEDLE
K
80
2666
APTEK ULTRASOUND PROCEDURE TRAY
K
76
1230
AMMOCENTESIS TRAY (KIT)
LHZ
Viscometer, Mucus, Cervical
MKO
Falloposcope
MOK
Vaginoscope And Accessories
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
NVT
Tubing And Tubing/Filter Fits
NWV
Laparoscopic Accessories, Gynecologic
NWW
Hysteroscope Accessories
PCF
Sampler, Endocervical
OHD
Gynecological Laparoscopic Kit
OHE
Forensic Evidence Sexual Assault Kit
OHF
Culdocentesis Kit
OHM
Cesarean Section Tray
OKX
Trocar Kit
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
OKZ
Endometrial Sampling Kit
OSV
Insufflator, Endoscopic Vessel Harvesting
PTZ
Colposcope (And Colpomicroscope), Exempt
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
QHZ
Seal, Cervical, Mechanical, Unpowered
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
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-b—obstetrical-and-gynecological-diagnostic-devices
/
HIO
/
K844558
View Source
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844558
510(k) Type
Traditional
Applicant
UNIVERSAL MEDICAL INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/31/1985
Days to Decision
71 days