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
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
K
24
1500
Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
2
Cleared 510(K)
K
24
0663
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
2
Cleared 510(K)
K
24
0283
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
2
Cleared 510(K)
K
23
2837
Uro-G HD Flexible Cystoscope
2
Cleared 510(K)
K
23
1118
Cystoscope System
2
Cleared 510(K)
K
22
3926
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
2
Cleared 510(K)
K
23
1702
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
2
Cleared 510(K)
K
22
3040
Endo SmartCap
2
Cleared 510(K)
K
22
1683
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
2
Cleared 510(K)
K
22
1690
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
2
Cleared 510(K)
K
22
1580
Single-Use Flexible Cystoscope
2
Cleared 510(K)
K
22
2162
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
2
Cleared 510(K)
K
22
2602
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
2
Cleared 510(K)
K
21
2202
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
2
Cleared 510(K)
K
21
2476
KARL STORZ Flexible HD Cysto-Urethroscope System
2
Cleared 510(K)
K
21
0512
LUMINELLE DTx System
2
Cleared 510(K)
K
20
2921
Uro-G Cystoscope
2
Cleared 510(K)
K
20
2957
Flexible Video Cysto-Urethroscope (C-view)
2
Cleared 510(K)
K
19
3095
Ambu aScope 4 Cysto
2
Cleared 510(K)
K
19
1357
Flexible HD Cysto-Urethroscope System
2
Cleared 510(K)
K
18
2876
Uro-N Cystoscope
2
Cleared 510(K)
K
18
2723
Flexible HD Cysto-Urethroscope System
2
Cleared 510(K)
K
18
1909
Luminelle DTx Hysteroscopy System
2
Cleared 510(K)
K
17
1500
Uro-V Cystoscope
2
Cleared 510(K)
K
17
0862
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
2
Cleared 510(K)
K
17
1336
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
2
Cleared 510(K)
K
16
0766
Ambu USR, Ambu M
2
Cleared 510(K)
K
14
2194
CytoSure Urinary Access System
2
Cleared 510(K)
K
12
0766
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
2
Cleared 510(K)
K
09
3725
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
2
Cleared 510(K)
K
09
3665
ENDO SMARTCAP
2
Cleared 510(K)
K
09
0814
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
2
Cleared 510(K)
K
07
2180
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
2
Cleared 510(K)
K
06
0899
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
2
Cleared 510(K)
K
05
3560
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
2
Cleared 510(K)
K
05
1176
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
2
Cleared 510(K)
K
04
3022
STRYKER FLEXIBLE CYSTONEPHROSCOPE
2
Cleared 510(K)
K
04
2780
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
2
Cleared 510(K)
K
04
2225
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
2
Cleared 510(K)
K
04
0215
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
2
Cleared 510(K)
K
03
3191
SOHNIKS
2
Cleared 510(K)
K
03
0960
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
2
Cleared 510(K)
K
03
1141
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
2
Cleared 510(K)
K
02
1074
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
2
Cleared 510(K)
K
01
2929
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
2
Cleared 510(K)
K
00
3988
UROSCOPE, ARTES MEDICAL, USA
2
Cleared 510(K)
K
00
3807
CYSTOSCOPES
2
Cleared 510(K)
K
99
3041
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
00
0197
CORTEK CYSTOSCOPE
2
Cleared 510(K)
K
99
3689
AED CYSTOSCOPE
2
Cleared 510(K)
K
99
2983
BAHO AUTOCLAVABLE CYSTOSCOPE
2
Cleared 510(K)
K
99
2483
MEDIFIX INC.
2
Cleared 510(K)
K
98
2620
MEDIVISION CYSTOSCOPE
2
Cleared 510(K)
K
98
0401
FLEXIBLE FIBERSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
98
0592
NTECH CYSTOSCOPES
2
Cleared 510(K)
K
97
0892
FIEGERT ENDOTECH CYSTOSCOPE
2
Cleared 510(K)
K
96
4037
FLEXIBLE CYSTOSCOPE
2
Cleared 510(K)
K
96
0872
CYSTOSCOPE 0/15/30/70 DEGREES
2
Cleared 510(K)
K
95
3201
IMAGYN UROSCOPE
2
Cleared 510(K)
K
94
5262
OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
2
Cleared 510(K)
K
94
5527
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
2
Cleared 510(K)
K
94
3176
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
2
Cleared 510(K)
K
94
1779
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
2
Cleared 510(K)
K
93
5278
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE
2
Cleared 510(K)
K
93
0827
BARD STABILIZING CANNULA
2
Cleared 510(K)
K
92
2320
OMNI CYSTOSCOPE
2
Cleared 510(K)
K
91
4008
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
2
Cleared 510(K)
K
90
2274
CUSTOMED CYSTO PACK I
2
Cleared 510(K)
K
89
5182
ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
2
Cleared 510(K)
K
86
0822
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
2
Cleared 510(K)
K
82
0851
CURITY ECONOMY II CYSTOSCOPY TRAY
2
Cleared 510(K)
K
76
0189
STOPCOCK, WATERLINE
2
Cleared 510(K)
K
76
0179
SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR
2
Cleared 510(K)
K
76
0274
TIP, RUBBER, PERFORATED
2
Cleared 510(K)
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
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
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Hematology
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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
/
FAJ
/
K171336
View Source
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171336
510(k) Type
Traditional
Applicant
Henke-Sass, Wolf GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
12/7/2017
Days to Decision
213 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
K
24
1500
Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
K
24
0663
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
K
24
0283
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
K
23
2837
Uro-G HD Flexible Cystoscope
K
23
1118
Cystoscope System
K
22
3926
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
K
23
1702
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
K
22
3040
Endo SmartCap
K
22
1683
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
K
22
1690
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
K
22
1580
Single-Use Flexible Cystoscope
K
22
2162
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K
22
2602
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
K
21
2202
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
K
21
2476
KARL STORZ Flexible HD Cysto-Urethroscope System
K
21
0512
LUMINELLE DTx System
K
20
2921
Uro-G Cystoscope
K
20
2957
Flexible Video Cysto-Urethroscope (C-view)
K
19
3095
Ambu aScope 4 Cysto
K
19
1357
Flexible HD Cysto-Urethroscope System
K
18
2876
Uro-N Cystoscope
K
18
2723
Flexible HD Cysto-Urethroscope System
K
18
1909
Luminelle DTx Hysteroscopy System
K
17
1500
Uro-V Cystoscope
K
17
0862
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
K
17
1336
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
K
16
0766
Ambu USR, Ambu M
K
14
2194
CytoSure Urinary Access System
K
12
0766
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
K
09
3725
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
K
09
3665
ENDO SMARTCAP
K
09
0814
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K
07
2180
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
K
06
0899
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
K
05
3560
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
K
05
1176
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
K
04
3022
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K
04
2780
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
K
04
2225
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K
04
0215
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
K
03
3191
SOHNIKS
K
03
0960
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
K
03
1141
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
K
02
1074
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K
01
2929
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
K
00
3988
UROSCOPE, ARTES MEDICAL, USA
K
00
3807
CYSTOSCOPES
K
99
3041
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
K
00
0197
CORTEK CYSTOSCOPE
K
99
3689
AED CYSTOSCOPE
K
99
2983
BAHO AUTOCLAVABLE CYSTOSCOPE
K
99
2483
MEDIFIX INC.
K
98
2620
MEDIVISION CYSTOSCOPE
K
98
0401
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K
98
0592
NTECH CYSTOSCOPES
K
97
0892
FIEGERT ENDOTECH CYSTOSCOPE
K
96
4037
FLEXIBLE CYSTOSCOPE
K
96
0872
CYSTOSCOPE 0/15/30/70 DEGREES
K
95
3201
IMAGYN UROSCOPE
K
94
5262
OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
K
94
5527
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K
94
3176
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
K
94
1779
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K
93
5278
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE
K
93
0827
BARD STABILIZING CANNULA
K
92
2320
OMNI CYSTOSCOPE
K
91
4008
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K
90
2274
CUSTOMED CYSTO PACK I
K
89
5182
ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
K
86
0822
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
K
82
0851
CURITY ECONOMY II CYSTOSCOPY TRAY
K
76
0189
STOPCOCK, WATERLINE
K
76
0179
SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR
K
76
0274
TIP, RUBBER, PERFORATED
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
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
/
FAJ
/
K171336
View Source
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171336
510(k) Type
Traditional
Applicant
Henke-Sass, Wolf GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
12/7/2017
Days to Decision
213 days
Submission Type
Summary