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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
K
24
0434
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
2
Cleared 510(K)
K
20
1952
CrossGlide ETS Plus
2
Cleared 510(K)
K
19
2534
CrossBay Endometrial Tissue Sampler (ETS)
2
Cleared 510(K)
K
10
2847
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
2
Cleared 510(K)
K
09
2982
THE PANPAC SUCTION CURETTE
2
Cleared 510(K)
K
05
1294
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
2
Cleared 510(K)
K
04
0189
ENDOMETRIAL SAMPLING SYRINGE
2
Cleared 510(K)
K
02
1876
MAS WITH OR WITHOUT SYRINGE
2
Cleared 510(K)
K
02
0628
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
2
Cleared 510(K)
K
00
1555
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
2
Cleared 510(K)
K
00
1545
PIPET CURET
2
Cleared 510(K)
K
00
0974
FOWLER ENDOCURETTE, MODEL CUR-XXX
2
Cleared 510(K)
K
00
0026
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
2
Cleared 510(K)
K
99
2926
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
2
Cleared 510(K)
K
99
1895
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
2
Cleared 510(K)
K
99
0387
ENDOMETRIAL SAMPLER
2
Cleared 510(K)
K
97
4819
SELECTCELLS(TM) MINI
2
Cleared 510(K)
K
96
0239
CPR D & C TRAY
2
Cleared 510(K)
K
95
4097
SELECTCELLS STANDARD
2
Cleared 510(K)
K
95
2652
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
2
Cleared 510(K)
K
91
5491
CURELLE
2
Cleared 510(K)
K
91
4241
PIONEER PRO-PUMP DUAL CONTROL
2
Cleared 510(K)
K
91
4220
PIONEER PRO-PUMP
2
Cleared 510(K)
K
88
1456
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE
2
Cleared 510(K)
K
87
5084
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
2
Cleared 510(K)
K
87
2908
ENDOMETRIAL SAMPLER
2
Cleared 510(K)
K
85
3216
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
2
Cleared 510(K)
K
85
4415
ENDOMETRIAL PIPELLE
2
Cleared 510(K)
K
82
3080
VAKUTAGE
2
Cleared 510(K)
K
82
3006
MEDEVICES ASPIRATION HOSE
2
Cleared 510(K)
K
82
2382
U.V.A.C. HANDLER SET
2
Cleared 510(K)
K
81
2426
UTERINE ASPIRATION CURETTES(RIGID&FLEX)
2
Cleared 510(K)
K
80
3210
MENSTRUAL ASPIRATION KITS
2
Cleared 510(K)
K
80
1070
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
2
Cleared 510(K)
K
79
1765
MASTERSON* ENDOMETRIAL BIOPSY KIT
2
Cleared 510(K)
K
79
0875
MONOJECT ENDOMETRIAL SAMPLING KIT
2
Cleared 510(K)
K
78
1830
BIOPSY KIT 781101, ASPIRATION
2
Cleared 510(K)
K
77
2121
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
2
Cleared 510(K)
K
77
1149
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
2
Cleared 510(K)
K
77
0674
CURETTE, UTERINE, VACUUM ASPIRATING
2
Cleared 510(K)
K
76
0264
CURETTE, PROPOSED TIS-U-TRAP, METAL
2
Cleared 510(K)
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
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 20 December 2024 at 11:05 pm
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HHK
/
K822382
View Source
U.V.A.C. HANDLER SET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K822382
510(k) Type
Traditional
Applicant
AMERICAN HOSPITAL SUPPLY CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/1982
Days to Decision
16 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)
K
24
0434
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K
20
1952
CrossGlide ETS Plus
K
19
2534
CrossBay Endometrial Tissue Sampler (ETS)
K
10
2847
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
K
09
2982
THE PANPAC SUCTION CURETTE
K
05
1294
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
K
04
0189
ENDOMETRIAL SAMPLING SYRINGE
K
02
1876
MAS WITH OR WITHOUT SYRINGE
K
02
0628
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K
00
1555
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
K
00
1545
PIPET CURET
K
00
0974
FOWLER ENDOCURETTE, MODEL CUR-XXX
K
00
0026
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
K
99
2926
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K
99
1895
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
K
99
0387
ENDOMETRIAL SAMPLER
K
97
4819
SELECTCELLS(TM) MINI
K
96
0239
CPR D & C TRAY
K
95
4097
SELECTCELLS STANDARD
K
95
2652
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
K
91
5491
CURELLE
K
91
4241
PIONEER PRO-PUMP DUAL CONTROL
K
91
4220
PIONEER PRO-PUMP
K
88
1456
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE
K
87
5084
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K
87
2908
ENDOMETRIAL SAMPLER
K
85
3216
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
K
85
4415
ENDOMETRIAL PIPELLE
K
82
3080
VAKUTAGE
K
82
3006
MEDEVICES ASPIRATION HOSE
K
82
2382
U.V.A.C. HANDLER SET
K
81
2426
UTERINE ASPIRATION CURETTES(RIGID&FLEX)
K
80
3210
MENSTRUAL ASPIRATION KITS
K
80
1070
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
K
79
1765
MASTERSON* ENDOMETRIAL BIOPSY KIT
K
79
0875
MONOJECT ENDOMETRIAL SAMPLING KIT
K
78
1830
BIOPSY KIT 781101, ASPIRATION
K
77
2121
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
K
77
1149
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K
77
0674
CURETTE, UTERINE, VACUUM ASPIRATING
K
76
0264
CURETTE, PROPOSED TIS-U-TRAP, METAL
HIF
Insufflator, Laparoscopic
HIG
Insufflator, Hysteroscopic
HIH
Hysteroscope (And Accessories)
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
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
/
HHK
/
K822382
View Source
U.V.A.C. HANDLER SET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K822382
510(k) Type
Traditional
Applicant
AMERICAN HOSPITAL SUPPLY CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/1982
Days to Decision
16 days