FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
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
K
24
2536
TauTona Pneumoperitoneum Assist Device (TPAD)
2
Cleared 510(K)
K
23
2902
EVA15 insufflator
2
Cleared 510(K)
K
23
2464
VereSee Optical Veres Needle System
2
Cleared 510(K)
K
23
3020
TauTona Pneumoperitoneum Assist Device (TPAD)
2
Cleared 510(K)
K
23
2401
Disposable Veress Needles
2
Cleared 510(K)
K
23
1342
Insufflator (OPTO-IFL1000)
2
Cleared 510(K)
K
23
0239
AirSeal iFS System; AirSeal dV Solution
2
Cleared 510(K)
K
23
1407
StarFin
2
Cleared 510(K)
K
22
2812
Insufflator
2
Cleared 510(K)
K
22
1995
Gas Insufflator
2
Cleared 510(K)
K
22
2901
EVA15 insufflator
2
Cleared 510(K)
K
21
2786
LevaLap Laparoscopic Access Device
2
Cleared 510(K)
K
21
1104
AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
2
Cleared 510(K)
K
20
2799
EVA15
2
Cleared 510(K)
K
20
1361
PNEUMOCLEAR
2
Cleared 510(K)
K
19
3520
EVA 15 Insufflator
2
Cleared 510(K)
K
19
3339
GTK Veress Needles
2
Cleared 510(K)
K
19
1780
AP50/30 Insufflator with Insuflow Port
2
Cleared 510(K)
K
19
0303
AirSeal
2
Cleared 510(K)
K
17
2835
GRI-Alleset Veress Needle
2
Cleared 510(K)
K
17
2516
SurgiQuest AIRSEAL iFS System
2
Cleared 510(K)
K
17
3545
TEMED Gas Diffuser
2
Cleared 510(K)
K
17
0799
AP 50/30 Insufflator with Insuflow Port
2
Cleared 510(K)
K
16
2582
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
2
Cleared 510(K)
K
17
1139
LaparoLight Veress Needle
2
Cleared 510(K)
K
17
0784
PNEUMOCLEAR
2
Cleared 510(K)
K
16
1554
ENDOFLATOR 40, ENDOFLATOR 50
2
Cleared 510(K)
K
16
2648
U-Blade Veress Needle
2
Cleared 510(K)
K
15
3367
S698 Symbioz flow
2
Cleared 510(K)
K
15
3513
Insufflator 50L FM134
2
Cleared 510(K)
K
15
0068
Unimicro Veress Needle
2
Cleared 510(K)
K
14
3404
SurgiQuest AirSeal iFS System
2
Cleared 510(K)
K
14
2700
InsufflatOR Needle
2
Cleared 510(K)
K
14
0263
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
2
Cleared 510(K)
K
13
2203
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
2
Cleared 510(K)
K
13
2204
INSUFLOW SYNERGY XL PORT
2
Cleared 510(K)
K
12
2180
HIGH FLOW INSUFFLANTION UNIT
2
Cleared 510(K)
K
12
0151
NEBULAE I
2
Cleared 510(K)
K
12
0640
INSUFLOW SYNERGY PORT
2
Cleared 510(K)
K
12
1336
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
2
Cleared 510(K)
K
11
2975
CARBONAID C02 DIFFUSER
2
Cleared 510(K)
K
11
0294
HIGH FLOW INSUFFLATION UNIT UHI-4
2
Cleared 510(K)
K
11
1955
MEDLINE PNEUMOPERITONEUM NEEDLE
2
Cleared 510(K)
K
11
2357
VESSEL GUARDIAN
2
Cleared 510(K)
K
11
1441
UNIMAX VERESS NEEDLE
2
Cleared 510(K)
K
10
3692
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
2
Cleared 510(K)
K
10
2136
VESSEL GUARDIAN
2
Cleared 510(K)
K
10
1320
VASOVAPOR
2
Cleared 510(K)
K
09
0652
ALPHA DUO LAP INSUFFLATOR
2
Cleared 510(K)
K
09
1366
INSUFLOW DEWHEART
2
Cleared 510(K)
K
09
0456
INSUFLOW
2
Cleared 510(K)
K
08
0852
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
2
Cleared 510(K)
K
07
2753
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
2
Cleared 510(K)
K
07
3452
MODIFICATION TO: ARAGON SURGICAL LAPCAP
2
Cleared 510(K)
K
07
0783
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
2
Cleared 510(K)
K
07
0651
ARAGON SURGICAL LAPCAP
2
Cleared 510(K)
K
06
3367
45L CORE INSUFFLATOR, MODEL F114
2
Cleared 510(K)
K
06
3546
INSUFLOW DEVICE, MODEL 6198
2
Cleared 510(K)
K
06
1387
VERESURE BELL
2
Cleared 510(K)
K
06
0723
40 L HIGH FLOW INSUFFLATOR F113
2
Cleared 510(K)
K
05
2125
CARBONAID GAS DIFFUSER
2
Cleared 510(K)
K
04
1560
FLO-ASSISTANT
2
Cleared 510(K)
K
03
3614
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
2
Cleared 510(K)
K
03
0837
40 L HIGH FLOW INSUFFLATOR F108
2
Cleared 510(K)
K
03
3991
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
2
Cleared 510(K)
K
03
1014
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
2
Cleared 510(K)
K
03
0469
LAPAROSHIELD CONDITIONED INSUFFLATION SET
2
Cleared 510(K)
K
02
2052
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
2
Cleared 510(K)
K
02
1247
PNEUMOPERITONEUM INSUFFLATION NEEDLE
2
Cleared 510(K)
K
02
2318
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
2
Cleared 510(K)
K
01
4166
UHI-3 HIGH FLOW INSUFFLATION UNIT
2
Cleared 510(K)
K
01
1510
MULTI HI-FLO PNEU, WISAP #7080
2
Cleared 510(K)
K
01
0053
HUMI-FLOW, MODEL 6-850-00/ 01/02
2
Cleared 510(K)
K
00
2328
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
2
Cleared 510(K)
K
00
0180
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
2
Cleared 510(K)
K
00
3703
TAUT-INSUFFLATION NEEDLE
2
Cleared 510(K)
K
00
3792
STRYKER HEATED INSUFFLATOR TUBE SET
2
Cleared 510(K)
K
00
1533
SURGIFLATOR-40
2
Cleared 510(K)
K
99
3625
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
2
Cleared 510(K)
K
00
1068
NBS CONNECTING TUBE SET
2
Cleared 510(K)
K
00
0027
INSUFFLATION NEEDLE, MODEL R65-933
2
Cleared 510(K)
K
99
1906
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
2
Cleared 510(K)
K
99
0662
DISPOSABLE HEATING TUBING SET #7642HSES
2
Cleared 510(K)
K
99
2381
CO2 GAS WARMER II, MODEL 6-800-00
2
Cleared 510(K)
K
98
3326
OMNIFLATOR 7640 MODEL 7-640-00
2
Cleared 510(K)
K
98
3925
ENDOPATH ULTRA VERESS NEEDLE
2
Cleared 510(K)
K
97
3447
OMNIFLATOR 6630(6-630-00)
2
Cleared 510(K)
K
97
2675
CO2 GAS WARMING UNIT (6-800-00)
2
Cleared 510(K)
K
98
1334
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
2
Cleared 510(K)
K
98
1859
SURGIFLATOR-20 ECU
2
Cleared 510(K)
K
98
0134
KSEA N2O ENDOFLATOR
2
Cleared 510(K)
K
97
0866
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
2
Cleared 510(K)
K
97
3432
SURGIFLATOR-30
2
Cleared 510(K)
K
95
5477
HI-TEC CO2 INSUFFLATOR TYPE 1300
2
Cleared 510(K)
K
96
3423
KSEA CO2 ENDOFLATOR
2
Cleared 510(K)
K
96
2683
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
2
Cleared 510(K)
K
95
5393
NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
2
Cleared 510(K)
K
95
5791
SURGIFLATOR-20 PIM
2
Cleared 510(K)
K
95
5073
KSEA THERMOFLATOR (MODEL 26 4320 20)
2
Cleared 510(K)
K
96
2863
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
2
Cleared 510(K)
K
95
0035
SURGIFLATOR 20
2
Cleared 510(K)
K
95
3162
OLYMPUS HIGH FLOW INSUFFLATION UNIT
2
Cleared 510(K)
K
95
1694
ELECTRONIC LAPAROFLATOR
2
Cleared 510(K)
K
95
1961
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
2
Cleared 510(K)
K
94
1438
OP-PNEU ELECTRONIC CO2
2
Cleared 510(K)
K
93
0013
CO2 INSUFFLATOR 1100
2
Cleared 510(K)
K
95
0219
ENDOLAP INSUFFLATOR TUBING SET
2
Cleared 510(K)
K
93
4115
3000 ELECTRONIC INSUFFLATOR MODIFICATION
2
Cleared 510(K)
K
94
5789
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
2
Cleared 510(K)
K
94
4509
DEXIDE INSUFFLATION TUBING WITH FILTER
2
Cleared 510(K)
K
93
4884
MODEL 2231 CO2 INSUFFLATOR
2
Cleared 510(K)
K
94
3954
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
2
Cleared 510(K)
K
93
5862
NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
2
Cleared 510(K)
K
94
2207
REFLEX INS INSUFFLATION NEEDLE
2
Cleared 510(K)
K
94
1685
DISPOSABLE FILTERED INSUFFLATION TUBING SET
2
Cleared 510(K)
K
93
4928
INSITE FILTER & TUBING SET
2
Cleared 510(K)
K
93
4926
INSITE MODEL 20 & MODEL 15 INSUFFLATORS
2
Cleared 510(K)
K
93
4114
KARL STORZ ELECTRONIC LAPAROFLATOR
2
Cleared 510(K)
K
93
4043
KARL STORZ ELECTRONIC LAPAROFLATOR
2
Cleared 510(K)
K
93
0696
SURE-FLO INSUFFLATION TUBING
2
Cleared 510(K)
K
93
3094
INSUFFLATOR TUBING KIT W/FILTER
2
Cleared 510(K)
K
93
0767
INSUFO-GARD #100-104
2
Cleared 510(K)
K
93
6155
ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA
2
Cleared 510(K)
K
92
1756
ELECTRONIC INSUFFLATOR MODEL 2054.61
2
Cleared 510(K)
K
92
4481
INSUFFLATION TUBING
2
Cleared 510(K)
K
92
2777
PRESSURE TUBING AND ACCESSORIES
2
Cleared 510(K)
K
93
5639
INSUFFLATION TUBING STERILE AND NON-STERILE
2
Cleared 510(K)
K
93
5503
DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
2
Cleared 510(K)
K
93
4131
DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
2
Cleared 510(K)
K
92
5558
INFILTUBE
2
Cleared 510(K)
K
93
0192
VCI INSUFLATOR FILTER W/ TUBING
2
Cleared 510(K)
K
92
0205
OTT INSUFFLATION FILTER TUBING
2
Cleared 510(K)
K
92
3194
INSUFFLATOR CONNECTING FILTER
2
Cleared 510(K)
K
92
2244
INSUFFLATOR TUBING/FILTER KIT
2
Cleared 510(K)
K
92
5691
INSUFFLATION TUBING
2
Cleared 510(K)
K
92
2245
SUPER-FLOW TUBING
2
Cleared 510(K)
K
92
1837
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
2
Cleared 510(K)
K
92
2038
CO2 INSUFFLATION TUBING
2
Cleared 510(K)
K
92
1264
SURGIFLATOR
2
Cleared 510(K)
K
91
3242
MICROPROCESSED CONTROLLED LAPAROFLATOR
2
Cleared 510(K)
K
92
1963
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
2
Cleared 510(K)
K
92
0959
INSUFFLATOR, LAPAROSCOPIC
2
Cleared 510(K)
K
91
5694
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
2
Cleared 510(K)
K
92
0986
SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700
2
Cleared 510(K)
K
91
5051
MODIFICATION MODEL 7201 INSUFFLATOR
2
Cleared 510(K)
K
92
0114
CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR
2
Cleared 510(K)
K
91
4153
OTT INSUFFLATOR FILTER PLUS/TUBING SET
2
Cleared 510(K)
K
91
3873
SYSTEM 3000 ELECTRONIC INSUFFLATOR
2
Cleared 510(K)
K
91
4201
LM- LAP 10 HIGH FLOW INSUFFLATOR
2
Cleared 510(K)
K
91
0983
IV 1000 INSUFFLATOR RAPID FLOW
2
Cleared 510(K)
K
91
4401
UNIVERSAL GENERAL USE KIT #7-510-16
2
Cleared 510(K)
K
91
4402
RECIRCULATION KIT #7-510-18
2
Cleared 510(K)
K
91
4403
GENERAL USE KIT #7-510-20
2
Cleared 510(K)
K
91
3979
ENDO I/A Y SET
2
Cleared 510(K)
K
91
4101
CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR
2
Cleared 510(K)
K
91
1179
VERRES NEEDLES 5 & 6 INCHES
2
Cleared 510(K)
K
91
3835
SNOWDEN-PENCER INSUFFLATOR TUBING SET
2
Cleared 510(K)
K
91
2044
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
2
Cleared 510(K)
K
91
1479
LAPAROSCOPIC INSUFLATION Y TUBING
2
Cleared 510(K)
K
91
0883
LAPAROFLATOR ELECTRONIC 3509
2
Cleared 510(K)
K
90
5481
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
2
Cleared 510(K)
K
90
5705
LAP 3501 HIGH FLOW INSUFFLATOR
2
Cleared 510(K)
K
90
5549
THE DART
2
Cleared 510(K)
K
90
5417
ELMED PNEUMOMAT DIGITAL
2
Cleared 510(K)
K
90
0808
RAPID AUTOMATIC PNEUMOPERITONEUM-I
2
Cleared 510(K)
K
90
0878
OTT INSUFFLATION FILTER TUBING
2
Cleared 510(K)
K
88
2185
ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60
2
Cleared 510(K)
K
87
1928
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
2
Cleared 510(K)
K
84
5021
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
2
Cleared 510(K)
K
81
2200
INSUFFLATOR
2
Cleared 510(K)
K
78
1913
INSUFFALATOR LAPARAOSCOPIC
2
Cleared 510(K)
K
77
2297
INSUFFLATOR, MODEL G100 & 200
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HIF
/
K001533
View Source
SURGIFLATOR-40
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001533
510(k) Type
Special
Applicant
W.O.M. GMHB
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2000
Days to Decision
75 days
Submission Type
Summary
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
K
24
2536
TauTona Pneumoperitoneum Assist Device (TPAD)
K
23
2902
EVA15 insufflator
K
23
2464
VereSee Optical Veres Needle System
K
23
3020
TauTona Pneumoperitoneum Assist Device (TPAD)
K
23
2401
Disposable Veress Needles
K
23
1342
Insufflator (OPTO-IFL1000)
K
23
0239
AirSeal iFS System; AirSeal dV Solution
K
23
1407
StarFin
K
22
2812
Insufflator
K
22
1995
Gas Insufflator
K
22
2901
EVA15 insufflator
K
21
2786
LevaLap Laparoscopic Access Device
K
21
1104
AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
K
20
2799
EVA15
K
20
1361
PNEUMOCLEAR
K
19
3520
EVA 15 Insufflator
K
19
3339
GTK Veress Needles
K
19
1780
AP50/30 Insufflator with Insuflow Port
K
19
0303
AirSeal
K
17
2835
GRI-Alleset Veress Needle
K
17
2516
SurgiQuest AIRSEAL iFS System
K
17
3545
TEMED Gas Diffuser
K
17
0799
AP 50/30 Insufflator with Insuflow Port
K
16
2582
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
K
17
1139
LaparoLight Veress Needle
K
17
0784
PNEUMOCLEAR
K
16
1554
ENDOFLATOR 40, ENDOFLATOR 50
K
16
2648
U-Blade Veress Needle
K
15
3367
S698 Symbioz flow
K
15
3513
Insufflator 50L FM134
K
15
0068
Unimicro Veress Needle
K
14
3404
SurgiQuest AirSeal iFS System
K
14
2700
InsufflatOR Needle
K
14
0263
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
K
13
2203
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
K
13
2204
INSUFLOW SYNERGY XL PORT
K
12
2180
HIGH FLOW INSUFFLANTION UNIT
K
12
0151
NEBULAE I
K
12
0640
INSUFLOW SYNERGY PORT
K
12
1336
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
K
11
2975
CARBONAID C02 DIFFUSER
K
11
0294
HIGH FLOW INSUFFLATION UNIT UHI-4
K
11
1955
MEDLINE PNEUMOPERITONEUM NEEDLE
K
11
2357
VESSEL GUARDIAN
K
11
1441
UNIMAX VERESS NEEDLE
K
10
3692
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
K
10
2136
VESSEL GUARDIAN
K
10
1320
VASOVAPOR
K
09
0652
ALPHA DUO LAP INSUFFLATOR
K
09
1366
INSUFLOW DEWHEART
K
09
0456
INSUFLOW
K
08
0852
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K
07
2753
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
K
07
3452
MODIFICATION TO: ARAGON SURGICAL LAPCAP
K
07
0783
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K
07
0651
ARAGON SURGICAL LAPCAP
K
06
3367
45L CORE INSUFFLATOR, MODEL F114
K
06
3546
INSUFLOW DEVICE, MODEL 6198
K
06
1387
VERESURE BELL
K
06
0723
40 L HIGH FLOW INSUFFLATOR F113
K
05
2125
CARBONAID GAS DIFFUSER
K
04
1560
FLO-ASSISTANT
K
03
3614
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K
03
0837
40 L HIGH FLOW INSUFFLATOR F108
K
03
3991
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
K
03
1014
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
K
03
0469
LAPAROSHIELD CONDITIONED INSUFFLATION SET
K
02
2052
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K
02
1247
PNEUMOPERITONEUM INSUFFLATION NEEDLE
K
02
2318
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
K
01
4166
UHI-3 HIGH FLOW INSUFFLATION UNIT
K
01
1510
MULTI HI-FLO PNEU, WISAP #7080
K
01
0053
HUMI-FLOW, MODEL 6-850-00/ 01/02
K
00
2328
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K
00
0180
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K
00
3703
TAUT-INSUFFLATION NEEDLE
K
00
3792
STRYKER HEATED INSUFFLATOR TUBE SET
K
00
1533
SURGIFLATOR-40
K
99
3625
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K
00
1068
NBS CONNECTING TUBE SET
K
00
0027
INSUFFLATION NEEDLE, MODEL R65-933
K
99
1906
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
K
99
0662
DISPOSABLE HEATING TUBING SET #7642HSES
K
99
2381
CO2 GAS WARMER II, MODEL 6-800-00
K
98
3326
OMNIFLATOR 7640 MODEL 7-640-00
K
98
3925
ENDOPATH ULTRA VERESS NEEDLE
K
97
3447
OMNIFLATOR 6630(6-630-00)
K
97
2675
CO2 GAS WARMING UNIT (6-800-00)
K
98
1334
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
K
98
1859
SURGIFLATOR-20 ECU
K
98
0134
KSEA N2O ENDOFLATOR
K
97
0866
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
K
97
3432
SURGIFLATOR-30
K
95
5477
HI-TEC CO2 INSUFFLATOR TYPE 1300
K
96
3423
KSEA CO2 ENDOFLATOR
K
96
2683
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
K
95
5393
NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
K
95
5791
SURGIFLATOR-20 PIM
K
95
5073
KSEA THERMOFLATOR (MODEL 26 4320 20)
K
96
2863
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
K
95
0035
SURGIFLATOR 20
K
95
3162
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K
95
1694
ELECTRONIC LAPAROFLATOR
K
95
1961
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K
94
1438
OP-PNEU ELECTRONIC CO2
K
93
0013
CO2 INSUFFLATOR 1100
K
95
0219
ENDOLAP INSUFFLATOR TUBING SET
K
93
4115
3000 ELECTRONIC INSUFFLATOR MODIFICATION
K
94
5789
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K
94
4509
DEXIDE INSUFFLATION TUBING WITH FILTER
K
93
4884
MODEL 2231 CO2 INSUFFLATOR
K
94
3954
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
K
93
5862
NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
K
94
2207
REFLEX INS INSUFFLATION NEEDLE
K
94
1685
DISPOSABLE FILTERED INSUFFLATION TUBING SET
K
93
4928
INSITE FILTER & TUBING SET
K
93
4926
INSITE MODEL 20 & MODEL 15 INSUFFLATORS
K
93
4114
KARL STORZ ELECTRONIC LAPAROFLATOR
K
93
4043
KARL STORZ ELECTRONIC LAPAROFLATOR
K
93
0696
SURE-FLO INSUFFLATION TUBING
K
93
3094
INSUFFLATOR TUBING KIT W/FILTER
K
93
0767
INSUFO-GARD #100-104
K
93
6155
ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA
K
92
1756
ELECTRONIC INSUFFLATOR MODEL 2054.61
K
92
4481
INSUFFLATION TUBING
K
92
2777
PRESSURE TUBING AND ACCESSORIES
K
93
5639
INSUFFLATION TUBING STERILE AND NON-STERILE
K
93
5503
DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
K
93
4131
DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
K
92
5558
INFILTUBE
K
93
0192
VCI INSUFLATOR FILTER W/ TUBING
K
92
0205
OTT INSUFFLATION FILTER TUBING
K
92
3194
INSUFFLATOR CONNECTING FILTER
K
92
2244
INSUFFLATOR TUBING/FILTER KIT
K
92
5691
INSUFFLATION TUBING
K
92
2245
SUPER-FLOW TUBING
K
92
1837
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
K
92
2038
CO2 INSUFFLATION TUBING
K
92
1264
SURGIFLATOR
K
91
3242
MICROPROCESSED CONTROLLED LAPAROFLATOR
K
92
1963
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
K
92
0959
INSUFFLATOR, LAPAROSCOPIC
K
91
5694
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K
92
0986
SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700
K
91
5051
MODIFICATION MODEL 7201 INSUFFLATOR
K
92
0114
CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR
K
91
4153
OTT INSUFFLATOR FILTER PLUS/TUBING SET
K
91
3873
SYSTEM 3000 ELECTRONIC INSUFFLATOR
K
91
4201
LM- LAP 10 HIGH FLOW INSUFFLATOR
K
91
0983
IV 1000 INSUFFLATOR RAPID FLOW
K
91
4401
UNIVERSAL GENERAL USE KIT #7-510-16
K
91
4402
RECIRCULATION KIT #7-510-18
K
91
4403
GENERAL USE KIT #7-510-20
K
91
3979
ENDO I/A Y SET
K
91
4101
CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR
K
91
1179
VERRES NEEDLES 5 & 6 INCHES
K
91
3835
SNOWDEN-PENCER INSUFFLATOR TUBING SET
K
91
2044
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
K
91
1479
LAPAROSCOPIC INSUFLATION Y TUBING
K
91
0883
LAPAROFLATOR ELECTRONIC 3509
K
90
5481
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K
90
5705
LAP 3501 HIGH FLOW INSUFFLATOR
K
90
5549
THE DART
K
90
5417
ELMED PNEUMOMAT DIGITAL
K
90
0808
RAPID AUTOMATIC PNEUMOPERITONEUM-I
K
90
0878
OTT INSUFFLATION FILTER TUBING
K
88
2185
ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60
K
87
1928
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
K
84
5021
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
K
81
2200
INSUFFLATOR
K
78
1913
INSUFFALATOR LAPARAOSCOPIC
K
77
2297
INSUFFLATOR, MODEL G100 & 200
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
/
HIF
/
K001533
View Source
SURGIFLATOR-40
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001533
510(k) Type
Special
Applicant
W.O.M. GMHB
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2000
Days to Decision
75 days
Submission Type
Summary