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Innolitics
Anesthesiology
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Review Panel
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Review Panel
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Gastroenterology and Urology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
FCP
Box, Battery, Pocket
1
Product Code
FCQ
Light Source, Incandescent, Diagnostic
2
Product Code
EXQ
Cystometer, Electrical Recording
2
Product Code
EXR
Urinometer, Mechanical
2
Product Code
EXS
Urinometer, Electrical
2
Product Code
EXW
Pill, Radio
2
Product Code
EXY
Uroflowmeter
2
Product Code
EXZ
Equipment, Photographic, For Physiologic Function Monitor
1
Product Code
FAJ
Cystoscope And Accessories, Flexible/Rigid
2
Product Code
FAK
Panendoscope (Gastroduodenoscope)
2
Product Code
FAL
Panendoscope (Urethroscope)
2
Product Code
FAM
Sigmoidoscope And Accessories, Flexible/Rigid
2
Product Code
FAN
Sigmoidoscope, Rigid, Electrical
2
Product Code
FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
2
Product Code
FBI
Rongeur, Cystoscopic
2
Product Code
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
2
Product Code
FBN
Choledochoscope And Accessories, Flexible/Rigid
2
Product Code
FBO
Cystourethroscope
2
Product Code
FBP
Telescope, Rigid, Endoscopic
2
Product Code
FCC
Endoscopic Magnetic Retriever
2
Product Code
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
2
Product Code
FCG
Biopsy Needle
2
Product Code
FCI
Punch, Biopsy
2
Product Code
FCK
Instrument, Biopsy, Suction
2
Product Code
FCL
Forceps, Biopsy, Non-Electric
1
Product Code
FCO
Box, Battery, Rechargeable
1
Product Code
FCR
Light Source, Photographic, Fiberoptic
2
Product Code
FCW
Light Source, Fiberoptic, Routine
2
Product Code
FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
2
Product Code
FCY
Bulb, Inflation, For Endoscope
1
Product Code
FCZ
Tube, Smoke Removal, Endoscopic
1
Product Code
FDA
Enteroscope And Accessories
2
Product Code
FDC
Resectoscope, Working Element
2
Product Code
FDE
Laparoscopy Kit
2
Product Code
FDF
Colonoscope And Accessories, Flexible/Rigid
2
Product Code
FDR
Sphyncteroscope
2
Product Code
FDS
Gastroscope And Accessories, Flexible/Rigid
2
Product Code
FDT
Duodenoscope And Accessories, Flexible/Rigid
2
Product Code
FDW
Esophagoscope, Rigid, Gastro-Urology
2
Product Code
FDX
Endoscopic Cytology Brush
2
Product Code
FDY
Device, Measuring, For Panendoscope
1
Product Code
FDZ
Attachment, Eyepiece, For Insertion Of Prescription Lens
1
Product Code
FEA
Attachment, Teaching, For Endoscope
1
Product Code
FEC
Obturator, For Endoscope
2
Product Code
FED
Endoscopic Access Overtube, Gastroenterology-Urology
2
Product Code
FEI
Instrument, Special Lens, For Endoscope
1
Product Code
FEJ
Attachment, Binocular, For Endoscope
1
Product Code
FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
1
Product Code
FEN
Device, Cystometric, Hydraulic
2
Product Code
FEQ
Pump, Air, Non-Manual, For Endoscope
2
Product Code
FER
Anoscope And Accessories
2
Product Code
FES
Recorder, External, Pressure, Amplifier & Transducer
2
Product Code
FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
2
Product Code
K
24
1371
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
2
Cleared 510(K)
K
22
2584
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
2
Cleared 510(K)
K
21
2808
Logic Hd camera head green, System green
2
Cleared 510(K)
K
22
1174
Telepack +
2
Cleared 510(K)
K
21
1332
D Camera Controller
2
Cleared 510(K)
K
20
2646
Visera Elite II Video System Center
2
Cleared 510(K)
K
20
1135
Image1 S CCU, Image1 S 4U Camera Head
2
Cleared 510(K)
K
20
1200
Visera Elite II Video System Center
2
Cleared 510(K)
K
20
0617
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
2
Cleared 510(K)
K
19
2286
FUJIFILM EP-6000 Video Processor
2
Cleared 510(K)
K
19
3235
Telepack +
2
Cleared 510(K)
K
19
0449
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
2
Cleared 510(K)
K
19
0648
Pusen Eview Medical Video Endoscope Image Processor
2
Cleared 510(K)
K
18
2696
Telepack X LED
2
Cleared 510(K)
K
18
0583
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
2
Cleared 510(K)
K
18
0414
EPX-4440FN Digital Video Processor with Light Source
2
Cleared 510(K)
K
17
2817
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
2
Cleared 510(K)
K
16
3675
Processor VP-7000, Light Source BL-7000
2
Cleared 510(K)
K
16
1204
ENDOCAM Flex HD Camera System 5521
2
Cleared 510(K)
K
16
0044
Image1 SPIES System
2
Cleared 510(K)
K
15
2109
HD-Camera HDC1000
2
Cleared 510(K)
K
15
0221
EPX-4440HD and EPX-4400HD with FICE
2
Cleared 510(K)
K
13
1953
IMAGE1 SPIES
2
Cleared 510(K)
K
13
0423
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
2
Cleared 510(K)
K
11
3873
PENTAX EPK-I5020 VIDEO PROCESSOR
2
Cleared 510(K)
K
11
1997
IMAGE1 GI CCU MODEL 22203020-114
2
Cleared 510(K)
K
10
2949
COLONOSCOPY ASSISTANT
2
Cleared 510(K)
K
10
2466
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
2
Cleared 510(K)
K
10
2059
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
2
Cleared 510(K)
K
09
0800
VS-100 ILLUMINATION AND IMAGING SYSTEM
2
Cleared 510(K)
K
08
3155
HD CAMERA HEAD OTV-S7PROH-HD-L08E
2
Cleared 510(K)
K
08
0809
IEC MEDSIGHT AND MEDBRIGHT
2
Cleared 510(K)
K
08
1585
ENDOSCOPY VIDEO CAMERA SYSTEM
2
Cleared 510(K)
K
07
0716
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
2
Cleared 510(K)
K
04
3324
AIDA WITH DICOM AND HL7 INTERFACE
2
Cleared 510(K)
K
04
1494
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
2
Cleared 510(K)
K
03
1895
KSEA OPSERVER LAP
2
Cleared 510(K)
K
03
2545
ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
2
Cleared 510(K)
K
03
2544
VP-1000; MED CAM 100; VP-3000A; MED CAM 300
2
Cleared 510(K)
K
02
3659
1-CCD ENDOCAM 5520 SYSTEM
2
Cleared 510(K)
K
02
0301
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
2
Cleared 510(K)
K
01
2660
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
2
Cleared 510(K)
K
01
3709
HILL-ROM PRIMAVIEW MONITOR SYSTEM
2
Cleared 510(K)
K
00
3325
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
00
3113
KSEA SCB-RUI SCO
2
Cleared 510(K)
K
00
3710
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
2
Cleared 510(K)
K
99
4348
KSEA SCB-RUI
2
Cleared 510(K)
K
99
4090
KARL STORZ AUTOCLAVABLE CAMERA HEAD
2
Cleared 510(K)
K
99
2469
KSEA SCBCOM
2
Cleared 510(K)
K
99
2362
FLEXISCOPE IQ 101
2
Cleared 510(K)
K
98
1856
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
2
Cleared 510(K)
K
98
1827
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
2
Cleared 510(K)
K
97
3798
S-357 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
97
3252
KARL STORZ DIRECT COUPLED CAMERA HEAD
2
Cleared 510(K)
K
97
2540
S-357 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
97
1416
OLYMPUS OES OTV-S5C VIDEO SYSTEM
2
Cleared 510(K)
K
97
1373
VISTA SINGLE CHIP VIDEO CAMERA
2
Cleared 510(K)
K
96
4173
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
2
Cleared 510(K)
K
96
2024
S-57 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
95
4451
EVIS 140 SYSTEM
2
Cleared 510(K)
K
95
4734
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
2
Cleared 510(K)
K
95
2482
KSEA REVERSE VIDEO
2
Cleared 510(K)
K
95
0417
EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
2
Cleared 510(K)
K
95
0974
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS
2
Cleared 510(K)
K
95
0975
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS
2
Cleared 510(K)
K
94
4620
SERIES 400 GASTROENTEROLOGY SYSTEM
2
Cleared 510(K)
K
94
4759
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
2
Cleared 510(K)
K
94
4254
OKTAS STEREO VIEWING SYSTEM
2
Cleared 510(K)
K
94
4081
OLYMPUS SWITCHING UNIT MODEL SU-1
2
Cleared 510(K)
K
94
0283
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
2
Cleared 510(K)
K
94
1919
OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
2
Cleared 510(K)
K
94
2141
EIDOLON ENDOSCOPE COUPLER
2
Cleared 510(K)
K
93
2312
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
2
Cleared 510(K)
K
93
4918
EPM-3300 VIDEO PROCESSOR
2
Cleared 510(K)
K
93
4623
ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
2
Cleared 510(K)
K
92
0026
NOBLES-LAI IMAGING SYSTEM
2
Cleared 510(K)
K
91
2447
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
2
Cleared 510(K)
K
91
2531
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
2
Cleared 510(K)
K
91
1485
COLOR VIDEO CAMERA
2
Cleared 510(K)
K
90
3459
PRECISION OPTICS ENDOSCOPE ADAPTER
2
Cleared 510(K)
K
90
3457
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
2
Cleared 510(K)
K
90
3458
PRECISION OPTICS IMAGE COUPLER
2
Cleared 510(K)
K
90
0380
MEDILASE 5010 ENDOSCOPE CONSOLE
2
Cleared 510(K)
K
87
0680
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
2
Cleared 510(K)
K
85
3585
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
2
Cleared 510(K)
K
84
3198
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
2
Cleared 510(K)
K
83
1412
CRM-100 COLOR VIDEO CAMERA
2
Cleared 510(K)
K
83
0924
CRM-114 COLOR VIDEO CAMERA
2
Cleared 510(K)
K
82
2959
ENDOSCOPIC VIDEOSYSTEM
2
Cleared 510(K)
K
82
0624
SYN-OPTICS #5200
2
Cleared 510(K)
K
81
0393
ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST.
2
Cleared 510(K)
FFF
Cover, Biopsy Forceps
1
Product Code
FFG
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
2
Product Code
FFS
Image, Illumination, Fiberoptic, For Endoscope
2
Product Code
FFT
Electrode, Ph, Stomach
1
Product Code
FFX
System, Gastrointestinal Motility (Electrical)
2
Product Code
FFY
Adaptor, Bulbs, Miscellaneous, For Endoscope
1
Product Code
FFZ
Cord, Electric, For Endoscope
2
Product Code
FGA
Kit, Nephroscope
2
Product Code
FGB
Ureteroscope And Accessories, Flexible/Rigid
2
Product Code
FGC
Urethroscope
2
Product Code
FGS
Carrier, Sponge, Endoscopic
2
Product Code
FHO
Pneumoperitoneum Needle
2
Product Code
FHP
Needle, Pneumoperitoneum, Simple
2
Product Code
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
2
Product Code
FJL
Resectoscope
2
Product Code
FTI
Lamp, Endoscope, Incandescent
2
Product Code
FTJ
Colonoscope, General & Plastic Surgery
2
Product Code
GCF
Proctoscope
2
Product Code
GCK
Gastroscope, General & Plastic Surgery
2
Product Code
GCL
Esophagoscope, General & Plastic Surgery
2
Product Code
GCM
Endoscope, Rigid
2
Product Code
GCN
Endoscope, Prism
2
Product Code
GCO
Endoscope, Mirror
2
Product Code
GCP
Endoscope, Ac-Powered And Accessories
2
Product Code
GCQ
Endoscope, Flexible
2
Product Code
GCS
Endoscope, Battery-Powered And Accessories
2
Product Code
GCT
Light Source, Endoscope, Xenon Arc
2
Product Code
GCW
Transformer, Endoscope
2
Product Code
GDB
Endoscope, Fiber Optic
2
Product Code
KDM
Sigmoidoscope, Rigid, Non-Electrical
2
Product Code
KDO
Rongeur, Cystoscopic, Hot
2
Product Code
KGD
Scissors For Cystoscope
2
Product Code
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
2
Product Code
KNW
Instrument, Biopsy
2
Product Code
MNK
Endoscopic Bite Block
1
Product Code
MNL
Accessories, Cleaning Brushes, For Endoscope
1
Product Code
MYE
System, Electrogastrography (Egg)
2
Product Code
NBG
Marker, Colon
2
Product Code
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
2
Product Code
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
2
Product Code
NLS
Instrument, Biopsy, Reprocessed
2
Product Code
NLX
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
2
Product Code
NMX
Needle And Needle Set, Gastro-Urology, Reprocessed
2
Product Code
NMY
Needle, Endoscopic, Reprocessed
2
Product Code
NON
Forceps, Biopsy, Non-Electric, Reprocessed
1
Product Code
NSI
System, Imaging, Esophageal, Wireless, Capsule
2
Product Code
NTN
Led Light Source
2
Product Code
NWB
Endoscope, Accessories, Narrow Band Spectrum
2
Product Code
NYV
Gastrointestinal Motility System, Capsule
2
Product Code
NWS
Kit, Choledochoscope, Flexible And Rigid
2
Product Code
NWT
Endoscopic Cholangiogram Kit
2
Product Code
NWU
Endoscope Introducer Kit
2
Product Code
OCS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
2
Product Code
OCT
Anti Fog Solution And Accessories, Endoscopy
2
Product Code
OCU
Endoscopic Storage Cover
2
Product Code
OCV
Endoscope Holder
2
Product Code
OCW
Endoscopic Tissue Approximation Device
2
Product Code
OCX
Endoscopic Irrigation/Suction System
2
Product Code
OCY
Endoscopic Guidewire, Gastroenterology-Urology
2
Product Code
OCZ
Endoscopic Grasping/Cutting Instrument, Non-Powered
2
Product Code
ODA
Endoscopic Central Control Unit
2
Product Code
ODB
Endoscopic Contamination Prevention Sheath
2
Product Code
ODC
Endoscope Channel Accessory
2
Product Code
ODD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
2
Product Code
ODE
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
2
Product Code
ODF
Mini Endoscope, Gastroenterology-Urology
2
Product Code
ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
2
Product Code
PCV
Endoscopic Leak Tester
2
Product Code
PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
2
Product Code
PGD
Colon Capsule Imaging System
2
Product Code
PGU
Spatial Imaging For Display Of Endoscope Position
2
Product Code
PHT
Basin For Endoscope Reprocessing
1
Product Code
PLL
Submucosal Injection Agent
2
Product Code
POZ
Biopsy Needle Kit
2
Product Code
PPE
Nephroscope Set
2
Product Code
PRV
Gastro-Urology Biopsy Kit
2
Product Code
PTQ
Endoscopic Magnetic Retriever, Exempt
2
Product Code
QFZ
Gastroenterology-Urology Accessories To A Biopsy Instrument
1
Product Code
PTR
Scissors For Cytoscope, Exempt
2
Product Code
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
2
Product Code
QIJ
Endoscopic Transhepatic Venous Access Needle
2
Product Code
QIS
Esophageal, Mucosal, Electrical Characterization
2
Product Code
QKZ
Magnetically Maneuvered Capsule Endoscopy System
2
Product Code
QNP
Gastrointesinal Lesion Software Detection System
2
Product Code
SBX
Software For Endoscopy Procedure Metrics
2
Product Code
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
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
GU
/
subpart-b—diagnostic-devices
/
FET
/
K944620
View Source
SERIES 400 GASTROENTEROLOGY SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K944620
510(k) Type
Traditional
Applicant
MARKS & MURASE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/27/1995
Days to Decision
219 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
FCP
Box, Battery, Pocket
FCQ
Light Source, Incandescent, Diagnostic
EXQ
Cystometer, Electrical Recording
EXR
Urinometer, Mechanical
EXS
Urinometer, Electrical
EXW
Pill, Radio
EXY
Uroflowmeter
EXZ
Equipment, Photographic, For Physiologic Function Monitor
FAJ
Cystoscope And Accessories, Flexible/Rigid
FAK
Panendoscope (Gastroduodenoscope)
FAL
Panendoscope (Urethroscope)
FAM
Sigmoidoscope And Accessories, Flexible/Rigid
FAN
Sigmoidoscope, Rigid, Electrical
FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FBI
Rongeur, Cystoscopic
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
FBN
Choledochoscope And Accessories, Flexible/Rigid
FBO
Cystourethroscope
FBP
Telescope, Rigid, Endoscopic
FCC
Endoscopic Magnetic Retriever
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
FCG
Biopsy Needle
FCI
Punch, Biopsy
FCK
Instrument, Biopsy, Suction
FCL
Forceps, Biopsy, Non-Electric
FCO
Box, Battery, Rechargeable
FCR
Light Source, Photographic, Fiberoptic
FCW
Light Source, Fiberoptic, Routine
FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
FCY
Bulb, Inflation, For Endoscope
FCZ
Tube, Smoke Removal, Endoscopic
FDA
Enteroscope And Accessories
FDC
Resectoscope, Working Element
FDE
Laparoscopy Kit
FDF
Colonoscope And Accessories, Flexible/Rigid
FDR
Sphyncteroscope
FDS
Gastroscope And Accessories, Flexible/Rigid
FDT
Duodenoscope And Accessories, Flexible/Rigid
FDW
Esophagoscope, Rigid, Gastro-Urology
FDX
Endoscopic Cytology Brush
FDY
Device, Measuring, For Panendoscope
FDZ
Attachment, Eyepiece, For Insertion Of Prescription Lens
FEA
Attachment, Teaching, For Endoscope
FEC
Obturator, For Endoscope
FED
Endoscopic Access Overtube, Gastroenterology-Urology
FEI
Instrument, Special Lens, For Endoscope
FEJ
Attachment, Binocular, For Endoscope
FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
FEN
Device, Cystometric, Hydraulic
FEQ
Pump, Air, Non-Manual, For Endoscope
FER
Anoscope And Accessories
FES
Recorder, External, Pressure, Amplifier & Transducer
FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
K
24
1371
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K
22
2584
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
K
21
2808
Logic Hd camera head green, System green
K
22
1174
Telepack +
K
21
1332
D Camera Controller
K
20
2646
Visera Elite II Video System Center
K
20
1135
Image1 S CCU, Image1 S 4U Camera Head
K
20
1200
Visera Elite II Video System Center
K
20
0617
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
K
19
2286
FUJIFILM EP-6000 Video Processor
K
19
3235
Telepack +
K
19
0449
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
K
19
0648
Pusen Eview Medical Video Endoscope Image Processor
K
18
2696
Telepack X LED
K
18
0583
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
K
18
0414
EPX-4440FN Digital Video Processor with Light Source
K
17
2817
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
K
16
3675
Processor VP-7000, Light Source BL-7000
K
16
1204
ENDOCAM Flex HD Camera System 5521
K
16
0044
Image1 SPIES System
K
15
2109
HD-Camera HDC1000
K
15
0221
EPX-4440HD and EPX-4400HD with FICE
K
13
1953
IMAGE1 SPIES
K
13
0423
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
K
11
3873
PENTAX EPK-I5020 VIDEO PROCESSOR
K
11
1997
IMAGE1 GI CCU MODEL 22203020-114
K
10
2949
COLONOSCOPY ASSISTANT
K
10
2466
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
K
10
2059
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
K
09
0800
VS-100 ILLUMINATION AND IMAGING SYSTEM
K
08
3155
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K
08
0809
IEC MEDSIGHT AND MEDBRIGHT
K
08
1585
ENDOSCOPY VIDEO CAMERA SYSTEM
K
07
0716
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K
04
3324
AIDA WITH DICOM AND HL7 INTERFACE
K
04
1494
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
K
03
1895
KSEA OPSERVER LAP
K
03
2545
ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
K
03
2544
VP-1000; MED CAM 100; VP-3000A; MED CAM 300
K
02
3659
1-CCD ENDOCAM 5520 SYSTEM
K
02
0301
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
K
01
2660
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
K
01
3709
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K
00
3325
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
K
00
3113
KSEA SCB-RUI SCO
K
00
3710
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
K
99
4348
KSEA SCB-RUI
K
99
4090
KARL STORZ AUTOCLAVABLE CAMERA HEAD
K
99
2469
KSEA SCBCOM
K
99
2362
FLEXISCOPE IQ 101
K
98
1856
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
K
98
1827
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
K
97
3798
S-357 VIDEO IMAGING SYSTEM
K
97
3252
KARL STORZ DIRECT COUPLED CAMERA HEAD
K
97
2540
S-357 VIDEO IMAGING SYSTEM
K
97
1416
OLYMPUS OES OTV-S5C VIDEO SYSTEM
K
97
1373
VISTA SINGLE CHIP VIDEO CAMERA
K
96
4173
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
K
96
2024
S-57 VIDEO IMAGING SYSTEM
K
95
4451
EVIS 140 SYSTEM
K
95
4734
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
K
95
2482
KSEA REVERSE VIDEO
K
95
0417
EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
K
95
0974
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS
K
95
0975
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS
K
94
4620
SERIES 400 GASTROENTEROLOGY SYSTEM
K
94
4759
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
K
94
4254
OKTAS STEREO VIEWING SYSTEM
K
94
4081
OLYMPUS SWITCHING UNIT MODEL SU-1
K
94
0283
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
K
94
1919
OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
K
94
2141
EIDOLON ENDOSCOPE COUPLER
K
93
2312
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
K
93
4918
EPM-3300 VIDEO PROCESSOR
K
93
4623
ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
K
92
0026
NOBLES-LAI IMAGING SYSTEM
K
91
2447
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
K
91
2531
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
K
91
1485
COLOR VIDEO CAMERA
K
90
3459
PRECISION OPTICS ENDOSCOPE ADAPTER
K
90
3457
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
K
90
3458
PRECISION OPTICS IMAGE COUPLER
K
90
0380
MEDILASE 5010 ENDOSCOPE CONSOLE
K
87
0680
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K
85
3585
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K
84
3198
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K
83
1412
CRM-100 COLOR VIDEO CAMERA
K
83
0924
CRM-114 COLOR VIDEO CAMERA
K
82
2959
ENDOSCOPIC VIDEOSYSTEM
K
82
0624
SYN-OPTICS #5200
K
81
0393
ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST.
FFF
Cover, Biopsy Forceps
FFG
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
FFS
Image, Illumination, Fiberoptic, For Endoscope
FFT
Electrode, Ph, Stomach
FFX
System, Gastrointestinal Motility (Electrical)
FFY
Adaptor, Bulbs, Miscellaneous, For Endoscope
FFZ
Cord, Electric, For Endoscope
FGA
Kit, Nephroscope
FGB
Ureteroscope And Accessories, Flexible/Rigid
FGC
Urethroscope
FGS
Carrier, Sponge, Endoscopic
FHO
Pneumoperitoneum Needle
FHP
Needle, Pneumoperitoneum, Simple
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
FJL
Resectoscope
FTI
Lamp, Endoscope, Incandescent
FTJ
Colonoscope, General & Plastic Surgery
GCF
Proctoscope
GCK
Gastroscope, General & Plastic Surgery
GCL
Esophagoscope, General & Plastic Surgery
GCM
Endoscope, Rigid
GCN
Endoscope, Prism
GCO
Endoscope, Mirror
GCP
Endoscope, Ac-Powered And Accessories
GCQ
Endoscope, Flexible
GCS
Endoscope, Battery-Powered And Accessories
GCT
Light Source, Endoscope, Xenon Arc
GCW
Transformer, Endoscope
GDB
Endoscope, Fiber Optic
KDM
Sigmoidoscope, Rigid, Non-Electrical
KDO
Rongeur, Cystoscopic, Hot
KGD
Scissors For Cystoscope
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
KNW
Instrument, Biopsy
MNK
Endoscopic Bite Block
MNL
Accessories, Cleaning Brushes, For Endoscope
MYE
System, Electrogastrography (Egg)
NBG
Marker, Colon
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
NLS
Instrument, Biopsy, Reprocessed
NLX
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
NMX
Needle And Needle Set, Gastro-Urology, Reprocessed
NMY
Needle, Endoscopic, Reprocessed
NON
Forceps, Biopsy, Non-Electric, Reprocessed
NSI
System, Imaging, Esophageal, Wireless, Capsule
NTN
Led Light Source
NWB
Endoscope, Accessories, Narrow Band Spectrum
NYV
Gastrointestinal Motility System, Capsule
NWS
Kit, Choledochoscope, Flexible And Rigid
NWT
Endoscopic Cholangiogram Kit
NWU
Endoscope Introducer Kit
OCS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
OCT
Anti Fog Solution And Accessories, Endoscopy
OCU
Endoscopic Storage Cover
OCV
Endoscope Holder
OCW
Endoscopic Tissue Approximation Device
OCX
Endoscopic Irrigation/Suction System
OCY
Endoscopic Guidewire, Gastroenterology-Urology
OCZ
Endoscopic Grasping/Cutting Instrument, Non-Powered
ODA
Endoscopic Central Control Unit
ODB
Endoscopic Contamination Prevention Sheath
ODC
Endoscope Channel Accessory
ODD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
ODE
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ODF
Mini Endoscope, Gastroenterology-Urology
ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
PCV
Endoscopic Leak Tester
PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
PGD
Colon Capsule Imaging System
PGU
Spatial Imaging For Display Of Endoscope Position
PHT
Basin For Endoscope Reprocessing
PLL
Submucosal Injection Agent
POZ
Biopsy Needle Kit
PPE
Nephroscope Set
PRV
Gastro-Urology Biopsy Kit
PTQ
Endoscopic Magnetic Retriever, Exempt
QFZ
Gastroenterology-Urology Accessories To A Biopsy Instrument
PTR
Scissors For Cytoscope, Exempt
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
QIJ
Endoscopic Transhepatic Venous Access Needle
QIS
Esophageal, Mucosal, Electrical Characterization
QKZ
Magnetically Maneuvered Capsule Endoscopy System
QNP
Gastrointesinal Lesion Software Detection System
SBX
Software For Endoscopy Procedure Metrics
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-b—diagnostic-devices
/
FET
/
K944620
View Source
SERIES 400 GASTROENTEROLOGY SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K944620
510(k) Type
Traditional
Applicant
MARKS & MURASE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/27/1995
Days to Decision
219 days
Submission Type
Statement