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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
K
24
2325
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
2
Cleared 510(K)
K
23
2043
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
2
Cleared 510(K)
K
23
1254
GripTract-GI Endoscopic Tissue Manipulator
2
Cleared 510(K)
K
23
2922
Pure-Vu EVS System
2
Cleared 510(K)
K
23
0332
Ambu® aScope™ Colon; Ambu® aBox™ 2
2
Cleared 510(K)
K
22
3827
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
2
Cleared 510(K)
K
23
0588
Aer-O-Scope Colonoscope System
2
Cleared 510(K)
K
22
1452
DiLumen C1, EZ1 and Tool Mount
2
Cleared 510(K)
K
21
3773
Insufflation Retention Device
2
Cleared 510(K)
K
22
0158
G-EYE System
2
Cleared 510(K)
K
21
3578
Balloon Dilatation Catheter
2
Cleared 510(K)
K
21
0052
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
2
Cleared 510(K)
K
22
0007
Pure-Vu EVS System
2
Cleared 510(K)
K
21
1819
DiLumen C2 and Tool Mount
2
Cleared 510(K)
K
21
0981
Pure Vu System
2
Cleared 510(K)
K
21
0851
DiLumen Endolumenal Interventional Platform (DiLumen)
2
Cleared 510(K)
K
20
2469
G-EYE System
2
Cleared 510(K)
K
19
2793
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
2
Cleared 510(K)
K
19
2588
G-EYE System
2
Cleared 510(K)
K
19
0669
Endotics
2
Cleared 510(K)
K
19
2664
FUJIFILM Endoscope Model EC-760Z-V/L
2
Cleared 510(K)
K
19
1220
Pure Vu System
2
Cleared 510(K)
K
19
0649
FUJIFILM Endoscope Model EC-760S-V/L
2
Cleared 510(K)
K
18
1084
PENTAX Video Colonoscopes (EC Family)
2
Cleared 510(K)
K
18
2540
DiLumen Endolumenal Interventional Platform
2
Cleared 510(K)
K
18
0285
PENTAX Medical Video Colonoscope EC34-i10T Series
2
Cleared 510(K)
K
18
1437
Pure Vu System
2
Cleared 510(K)
K
17
3317
DiLumen C2; DiLumen Tool Mount
2
Cleared 510(K)
K
18
0405
FUJIFILM Endoscope Models EC-600HL and EC-600LS
2
Cleared 510(K)
K
17
1673
Focus Cap
2
Cleared 510(K)
K
17
3085
invendoscopy E210 System
2
Cleared 510(K)
K
17
3392
Pure-Vu System
2
Cleared 510(K)
K
17
2036
Medrobotics Flex Robotic System
2
Cleared 510(K)
K
16
2330
Flex Robotic System and Flex Colorectal Drive
2
Cleared 510(K)
K
16
3492
Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
2
Cleared 510(K)
K
16
2428
DiLumen Endolumenal Interventional Platform
2
Cleared 510(K)
K
16
2622
Fujifilm Endoscope Models EC-600HL and EC-600LS
2
Cleared 510(K)
K
16
0015
Pure Vu
2
Cleared 510(K)
K
16
1355
invendoscopy E200 System
2
Cleared 510(K)
K
16
1791
Aer-O-Scope Colonoscope System
2
Cleared 510(K)
K
16
0356
Third Eye Panoramic Auxiliary Endoscopy System - Resposable
2
Cleared 510(K)
K
16
0196
Fujifilm Video Colonoscope Model EC-600WL V2
2
Cleared 510(K)
K
15
3483
Balloon controller PB-30
2
Cleared 510(K)
K
14
3732
FUJIFILM Endoscope Models EC-600HL and EC-600LS
2
Cleared 510(K)
K
14
0595
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
14
1598
FUSE COLONOSCOPY SYSTEM
2
Cleared 510(K)
K
14
1286
AER-O-SCOPE COLONOSCOPE SYSTEM
2
Cleared 510(K)
K
13
1855
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
2
Cleared 510(K)
K
13
2839
FUSE 1C COLONOSCOPY SYSTEM
2
Cleared 510(K)
K
13
2210
FUJIFILM 600 SERIES ENDOSCOPES
2
Cleared 510(K)
K
13
1780
EVIS EXERA III VIDEO SYSTEM
2
Cleared 510(K)
K
13
0718
PEERSCOPE SYSTEM
2
Cleared 510(K)
K
12
1582
INVENDO C25 COLONOSCOPY SYSTEM
2
Cleared 510(K)
K
12
0289
PEERSCOPE SYSTEM
2
Cleared 510(K)
K
11
2391
FUJINON COLONOSCOPES
2
Cleared 510(K)
K
11
3050
CLEARPATH LOWER GI
2
Cleared 510(K)
K
11
1756
V1 SYSTEM
2
Cleared 510(K)
K
10
0624
INVENDO C20 COLONOSCOPY SYSTEM
2
Cleared 510(K)
K
11
2680
EVIS EXERA III VIDEO SYSTEM
2
Cleared 510(K)
K
11
1028
EUS BALLOON
2
Cleared 510(K)
K
10
3312
UPD-Y0003
2
Cleared 510(K)
K
10
2616
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
2
Cleared 510(K)
K
10
0966
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
2
Cleared 510(K)
K
10
1191
NAVIAID ICVI DEVICE
2
Cleared 510(K)
K
10
1053
OLYMPUS CF TYPE Y0023-L, Y0023I
2
Cleared 510(K)
K
09
3037
PENTEX EC-3890LI
2
Cleared 510(K)
K
09
3187
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
09
1305
CLEARPATH
2
Cleared 510(K)
K
09
1783
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
2
Cleared 510(K)
K
09
0116
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
2
Cleared 510(K)
K
08
3180
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
08
1004
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
2
Cleared 510(K)
K
08
0317
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
2
Cleared 510(K)
K
07
0622
NEOGUIDE ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
07
0330
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
06
3654
ENDOGUIDE
2
Cleared 510(K)
K
06
3585
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
2
Cleared 510(K)
K
05
2930
NAVIGATOR ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
05
1068
ZUTRON COLONOSCOPE STIFFENING DEVICE
2
Cleared 510(K)
K
05
1541
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
2
Cleared 510(K)
K
04
3487
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
2
Cleared 510(K)
K
04
1903
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
2
Cleared 510(K)
K
03
2688
COLONOSIGHT MODEL 510B
2
Cleared 510(K)
K
02
3259
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
2
Cleared 510(K)
K
00
2749
ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
2
Cleared 510(K)
K
00
1241
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
2
Cleared 510(K)
K
97
0372
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
2
Cleared 510(K)
K
96
1570
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
2
Cleared 510(K)
K
96
1563
EC-384OTL, VIDEO COLONSCOPE
2
Cleared 510(K)
K
95
1574
EC-3800L, VIDEO COLONOSCOPE
2
Cleared 510(K)
K
95
1579
EC-3800TL, VIDEO COLONOSCOPE
2
Cleared 510(K)
K
95
4704
VS-200 VIDEO SIGMOIDOSCOPE
2
Cleared 510(K)
K
95
1575
FC-38TLH, FIBER COLONOSCOPE
2
Cleared 510(K)
K
95
1580
FC-38LH, FIBER COLONOSCCOPE
2
Cleared 510(K)
K
95
1578
FC-38LX, FIBER COLONOSCOPE
2
Cleared 510(K)
K
94
3895
VISION SYSTEM COLONSCOPE
2
Cleared 510(K)
K
90
1610
SULLIVAN VARIABLE STIFFNESS CABLE
2
Cleared 510(K)
K
88
4857
COLONOSCOPE GUIDING TUBE DEVICE
2
Cleared 510(K)
K
82
2846
PENTAX FC-38LA & FC-38SA COLONOFIBER
2
Cleared 510(K)
K
81
0682
PENTAX COLONOSCOPE MODEL FC-34LA
2
Cleared 510(K)
K
81
0791
PENTAX COLONOSCOPE MODEL FC-34 MA
2
Cleared 510(K)
K
81
0654
STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
2
Cleared 510(K)
K
80
1223
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
2
Cleared 510(K)
K
79
2179
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
2
Cleared 510(K)
K
79
0338
COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
2
Cleared 510(K)
K
76
0452
COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
2
Cleared 510(K)
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
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 30 November 2024 at 11:09 am
GU
/
subpart-b—diagnostic-devices
/
FDF
/
K001241
View Source
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001241
510(k) Type
Special
Applicant
THE OLYMPUS OPTICAL CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/9/2000
Days to Decision
21 days
Submission Type
Summary
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
K
24
2325
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
K
23
2043
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
K
23
1254
GripTract-GI Endoscopic Tissue Manipulator
K
23
2922
Pure-Vu EVS System
K
23
0332
Ambu® aScope™ Colon; Ambu® aBox™ 2
K
22
3827
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K
23
0588
Aer-O-Scope Colonoscope System
K
22
1452
DiLumen C1, EZ1 and Tool Mount
K
21
3773
Insufflation Retention Device
K
22
0158
G-EYE System
K
21
3578
Balloon Dilatation Catheter
K
21
0052
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
K
22
0007
Pure-Vu EVS System
K
21
1819
DiLumen C2 and Tool Mount
K
21
0981
Pure Vu System
K
21
0851
DiLumen Endolumenal Interventional Platform (DiLumen)
K
20
2469
G-EYE System
K
19
2793
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
K
19
2588
G-EYE System
K
19
0669
Endotics
K
19
2664
FUJIFILM Endoscope Model EC-760Z-V/L
K
19
1220
Pure Vu System
K
19
0649
FUJIFILM Endoscope Model EC-760S-V/L
K
18
1084
PENTAX Video Colonoscopes (EC Family)
K
18
2540
DiLumen Endolumenal Interventional Platform
K
18
0285
PENTAX Medical Video Colonoscope EC34-i10T Series
K
18
1437
Pure Vu System
K
17
3317
DiLumen C2; DiLumen Tool Mount
K
18
0405
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K
17
1673
Focus Cap
K
17
3085
invendoscopy E210 System
K
17
3392
Pure-Vu System
K
17
2036
Medrobotics Flex Robotic System
K
16
2330
Flex Robotic System and Flex Colorectal Drive
K
16
3492
Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
K
16
2428
DiLumen Endolumenal Interventional Platform
K
16
2622
Fujifilm Endoscope Models EC-600HL and EC-600LS
K
16
0015
Pure Vu
K
16
1355
invendoscopy E200 System
K
16
1791
Aer-O-Scope Colonoscope System
K
16
0356
Third Eye Panoramic Auxiliary Endoscopy System - Resposable
K
16
0196
Fujifilm Video Colonoscope Model EC-600WL V2
K
15
3483
Balloon controller PB-30
K
14
3732
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K
14
0595
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
K
14
1598
FUSE COLONOSCOPY SYSTEM
K
14
1286
AER-O-SCOPE COLONOSCOPE SYSTEM
K
13
1855
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
K
13
2839
FUSE 1C COLONOSCOPY SYSTEM
K
13
2210
FUJIFILM 600 SERIES ENDOSCOPES
K
13
1780
EVIS EXERA III VIDEO SYSTEM
K
13
0718
PEERSCOPE SYSTEM
K
12
1582
INVENDO C25 COLONOSCOPY SYSTEM
K
12
0289
PEERSCOPE SYSTEM
K
11
2391
FUJINON COLONOSCOPES
K
11
3050
CLEARPATH LOWER GI
K
11
1756
V1 SYSTEM
K
10
0624
INVENDO C20 COLONOSCOPY SYSTEM
K
11
2680
EVIS EXERA III VIDEO SYSTEM
K
11
1028
EUS BALLOON
K
10
3312
UPD-Y0003
K
10
2616
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
K
10
0966
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
K
10
1191
NAVIAID ICVI DEVICE
K
10
1053
OLYMPUS CF TYPE Y0023-L, Y0023I
K
09
3037
PENTEX EC-3890LI
K
09
3187
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K
09
1305
CLEARPATH
K
09
1783
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
K
09
0116
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K
08
3180
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K
08
1004
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
K
08
0317
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
K
07
0622
NEOGUIDE ENDOSCOPY SYSTEM
K
07
0330
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K
06
3654
ENDOGUIDE
K
06
3585
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K
05
2930
NAVIGATOR ENDOSCOPY SYSTEM
K
05
1068
ZUTRON COLONOSCOPE STIFFENING DEVICE
K
05
1541
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K
04
3487
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
K
04
1903
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
K
03
2688
COLONOSIGHT MODEL 510B
K
02
3259
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
K
00
2749
ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
K
00
1241
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
K
97
0372
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
K
96
1570
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
K
96
1563
EC-384OTL, VIDEO COLONSCOPE
K
95
1574
EC-3800L, VIDEO COLONOSCOPE
K
95
1579
EC-3800TL, VIDEO COLONOSCOPE
K
95
4704
VS-200 VIDEO SIGMOIDOSCOPE
K
95
1575
FC-38TLH, FIBER COLONOSCOPE
K
95
1580
FC-38LH, FIBER COLONOSCCOPE
K
95
1578
FC-38LX, FIBER COLONOSCOPE
K
94
3895
VISION SYSTEM COLONSCOPE
K
90
1610
SULLIVAN VARIABLE STIFFNESS CABLE
K
88
4857
COLONOSCOPE GUIDING TUBE DEVICE
K
82
2846
PENTAX FC-38LA & FC-38SA COLONOFIBER
K
81
0682
PENTAX COLONOSCOPE MODEL FC-34LA
K
81
0791
PENTAX COLONOSCOPE MODEL FC-34 MA
K
81
0654
STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
K
80
1223
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K
79
2179
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K
79
0338
COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
K
76
0452
COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
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
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
/
FDF
/
K001241
View Source
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001241
510(k) Type
Special
Applicant
THE OLYMPUS OPTICAL CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/9/2000
Days to Decision
21 days
Submission Type
Summary