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by
Innolitics
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Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
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Review Panel
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Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
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Obstetrical and Gynecological
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
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
K
21
0628
X-FLO Fluid Management System
2
Cleared 510(K)
K
20
1355
Endomat Select, IBS Shaver Software, License
2
Cleared 510(K)
K
18
0735
Endomat Select
2
Cleared 510(K)
K
18
0825
Fluent Fluid Management System
2
Cleared 510(K)
K
17
3489
GYN-Pump PH304
2
Cleared 510(K)
K
17
2040
Aquilex Fluid Control System AQL-100S
2
Cleared 510(K)
K
17
2048
FluidSmart
2
Cleared 510(K)
K
13
3799
THERMEDX FLUID MANAGMENT SYSTEM
2
Cleared 510(K)
K
12
3732
HYSTEROSCOPY PUMP HM6
2
Cleared 510(K)
K
11
2642
AQUILEX FLUID CONTROL SYSTEM H112
2
Cleared 510(K)
K
11
0852
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
2
Cleared 510(K)
K
09
1939
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
2
Cleared 510(K)
K
03
1616
IUR FLUID MANAGEMENT SYSTEM
2
Cleared 510(K)
K
03
1213
AQUASENS FLUID MONITORING SYSTEM
2
Cleared 510(K)
K
02
2449
HYSTEREOSCOPY PUMP HM4
2
Cleared 510(K)
K
01
1876
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
2
Cleared 510(K)
K
01
1069
AQUASENS FLUID MONITORING SYSTEM
2
Cleared 510(K)
K
00
0806
KARL STORZ HYSTEROMAT II
2
Cleared 510(K)
K
99
1799
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
2
Cleared 510(K)
K
98
2867
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
2
Cleared 510(K)
K
98
3889
HYS-SURGIFLATOR 150P
2
Cleared 510(K)
K
97
0078
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
2
Cleared 510(K)
K
97
1492
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
2
Cleared 510(K)
K
96
4136
HYSTERO CO2-PNEU 2221
2
Cleared 510(K)
K
96
1091
KARL STORZ MODEL 203020 20 EQUIMAT
2
Cleared 510(K)
K
93
4866
HYS-SURGIMAT
2
Cleared 510(K)
K
93
3847
HYS-SURGIFLATOR VP
2
Cleared 510(K)
K
95
0961
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
2
Cleared 510(K)
K
94
1743
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
2
Cleared 510(K)
K
92
4523
HYS-SURGIFLATOR
2
Cleared 510(K)
K
93
6231
THE KARL STORZ HAMOU ENDOMAT
2
Cleared 510(K)
K
93
3384
BARD HYSTERO-FLO II PUMP
2
Cleared 510(K)
K
93
3873
CONCEPT UNIVERSAL PUMP SYSTEM
2
Cleared 510(K)
K
92
1871
HYSTEROMAT(TM) 3700
2
Cleared 510(K)
K
93
0912
HYSTEROMED 100
2
Cleared 510(K)
K
92
2632
WOM HYSTEROFLATOR OP
2
Cleared 510(K)
K
93
1606
7-510-25 HYSTEROMED TUBING KIT
2
Cleared 510(K)
K
92
2197
INSUFFLATOR TUBING KIT
2
Cleared 510(K)
K
91
2498
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
2
Cleared 510(K)
K
91
1844
HYSTEROFLATOR 1500
2
Cleared 510(K)
K
91
2789
LM-100/200LOW FLOW INSUFFLATOR
2
Cleared 510(K)
K
90
5495
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
2
Cleared 510(K)
K
90
5706
GYN-1500 HYSTEROSCOPIC INUFFLATOR
2
Cleared 510(K)
K
90
1288
DAVOL SCOPE IRRIGATION SYSTEM
2
Cleared 510(K)
K
90
0908
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
2
Cleared 510(K)
K
89
4259
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
2
Cleared 510(K)
K
89
5659
HUI MINI-FLEX
2
Cleared 510(K)
K
89
5907
HYSTEROFLATOR 2001
2
Cleared 510(K)
K
89
2001
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
2
Cleared 510(K)
K
89
1028
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
2
Cleared 510(K)
K
88
1680
ACKRAD H/S PROCEDURE TRAY
2
Cleared 510(K)
K
87
3527
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
2
Cleared 510(K)
K
87
2860
INSUFFLATOR TUBING
2
Cleared 510(K)
K
84
2943
AXCAN UTERINE SUCCION INJECTOR
2
Cleared 510(K)
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 16 August 2024 at 11:05 pm
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HIG
/
K842943
View Source
AXCAN UTERINE SUCCION INJECTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K842943
510(k) Type
Traditional
Applicant
AXCAN SCIENTIFIC CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/1984
Days to Decision
58 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
K
21
0628
X-FLO Fluid Management System
K
20
1355
Endomat Select, IBS Shaver Software, License
K
18
0735
Endomat Select
K
18
0825
Fluent Fluid Management System
K
17
3489
GYN-Pump PH304
K
17
2040
Aquilex Fluid Control System AQL-100S
K
17
2048
FluidSmart
K
13
3799
THERMEDX FLUID MANAGMENT SYSTEM
K
12
3732
HYSTEROSCOPY PUMP HM6
K
11
2642
AQUILEX FLUID CONTROL SYSTEM H112
K
11
0852
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K
09
1939
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
K
03
1616
IUR FLUID MANAGEMENT SYSTEM
K
03
1213
AQUASENS FLUID MONITORING SYSTEM
K
02
2449
HYSTEREOSCOPY PUMP HM4
K
01
1876
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
K
01
1069
AQUASENS FLUID MONITORING SYSTEM
K
00
0806
KARL STORZ HYSTEROMAT II
K
99
1799
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
K
98
2867
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
K
98
3889
HYS-SURGIFLATOR 150P
K
97
0078
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
K
97
1492
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
K
96
4136
HYSTERO CO2-PNEU 2221
K
96
1091
KARL STORZ MODEL 203020 20 EQUIMAT
K
93
4866
HYS-SURGIMAT
K
93
3847
HYS-SURGIFLATOR VP
K
95
0961
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K
94
1743
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
K
92
4523
HYS-SURGIFLATOR
K
93
6231
THE KARL STORZ HAMOU ENDOMAT
K
93
3384
BARD HYSTERO-FLO II PUMP
K
93
3873
CONCEPT UNIVERSAL PUMP SYSTEM
K
92
1871
HYSTEROMAT(TM) 3700
K
93
0912
HYSTEROMED 100
K
92
2632
WOM HYSTEROFLATOR OP
K
93
1606
7-510-25 HYSTEROMED TUBING KIT
K
92
2197
INSUFFLATOR TUBING KIT
K
91
2498
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K
91
1844
HYSTEROFLATOR 1500
K
91
2789
LM-100/200LOW FLOW INSUFFLATOR
K
90
5495
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
K
90
5706
GYN-1500 HYSTEROSCOPIC INUFFLATOR
K
90
1288
DAVOL SCOPE IRRIGATION SYSTEM
K
90
0908
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K
89
4259
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
K
89
5659
HUI MINI-FLEX
K
89
5907
HYSTEROFLATOR 2001
K
89
2001
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K
89
1028
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
K
88
1680
ACKRAD H/S PROCEDURE TRAY
K
87
3527
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
K
87
2860
INSUFFLATOR TUBING
K
84
2943
AXCAN UTERINE SUCCION INJECTOR
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
/
HIG
/
K842943
View Source
AXCAN UTERINE SUCCION INJECTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K842943
510(k) Type
Traditional
Applicant
AXCAN SCIENTIFIC CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/1984
Days to Decision
58 days