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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
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
K
24
1639
Single-use Video Ureterorenoscope (SVU-220US)
2
Cleared 510(K)
K
24
1598
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)
2
Cleared 510(K)
K
23
3630
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
2
Cleared 510(K)
K
23
2911
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
2
Cleared 510(K)
K
24
0374
Ureterorenoscope System
2
Cleared 510(K)
K
23
3275
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
2
Cleared 510(K)
K
23
1135
Video Ureteroscope System
2
Cleared 510(K)
K
23
1774
CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
2
Cleared 510(K)
K
23
3645
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
2
Cleared 510(K)
K
23
0475
Medical Video Endoscope System
2
Cleared 510(K)
K
22
3097
RenaNav Ureteroscope System
2
Cleared 510(K)
K
23
1878
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
2
Cleared 510(K)
K
23
0200
Single-Use Flexible Ureteroscope
2
Cleared 510(K)
K
22
1158
Single-Use Video Flexible Ureterorenoscope System
2
Cleared 510(K)
K
22
3466
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101
2
Cleared 510(K)
K
22
1515
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
2
Cleared 510(K)
K
22
2737
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
2
Cleared 510(K)
K
22
0159
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
2
Cleared 510(K)
K
21
3334
Monarch Platform, Urology
2
Cleared 510(K)
K
21
1686
Flexible Video-Choledo-Cysto-Ureteroscope System
2
Cleared 510(K)
K
21
2458
Flexible Video-Uretero-Renoscope SSU System
2
Cleared 510(K)
K
21
1347
Uretero1 Ureteroscope System
2
Cleared 510(K)
K
21
0579
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
2
Cleared 510(K)
K
20
1897
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
2
Cleared 510(K)
K
20
0369
OES Elite Ureteroscopes and Accessories
2
Cleared 510(K)
K
20
1293
Ureterorenoscope System
2
Cleared 510(K)
K
18
3188
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
2
Cleared 510(K)
K
18
1451
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
2
Cleared 510(K)
K
18
1977
WiScope Digital Endoscope System
2
Cleared 510(K)
K
18
0367
Ureterorenoscope System
2
Cleared 510(K)
K
17
2246
OLYMPUS URF-V2/V2R
2
Cleared 510(K)
K
17
2298
OLYMPUS URF-P6/P6R
2
Cleared 510(K)
K
17
2098
Medical Video Endoscope System
2
Cleared 510(K)
K
17
1076
Medical Video Endoscope System
2
Cleared 510(K)
K
15
3049
LithoVue System
2
Cleared 510(K)
K
14
2556
Flexible Video-Uretero-Choledochoscope System
2
Cleared 510(K)
K
14
1250
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
2
Cleared 510(K)
K
13
1369
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
2
Cleared 510(K)
K
12
1112
STRYKER VIDEO URETEROSCOPE
2
Cleared 510(K)
K
11
1480
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
2
Cleared 510(K)
K
06
2707
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
2
Cleared 510(K)
K
06
2725
MAXIFLEX-SEMI FLEX SCOPE
2
Cleared 510(K)
K
05
2044
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
2
Cleared 510(K)
K
04
3021
STRYKER URETEROSCOPE
2
Cleared 510(K)
K
03
3651
OLYMPUS VIDEO URETEROSCOPE, NTSC
2
Cleared 510(K)
K
03
1278
STRYKER FLEXIBLE URETEROSCOPE
2
Cleared 510(K)
K
02
3358
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
2
Cleared 510(K)
K
01
2758
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
2
Cleared 510(K)
K
01
1849
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
2
Cleared 510(K)
K
01
2951
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
2
Cleared 510(K)
K
01
2925
DUR-8, MODELS DUR-8
2
Cleared 510(K)
K
01
1325
MEDIFIX URETEROSCOPE
2
Cleared 510(K)
K
00
3806
URETEROSCOPES
2
Cleared 510(K)
K
00
0200
CORTEK URETHEROSCOPE
2
Cleared 510(K)
K
99
2527
URETERO-RENOSCOPE
2
Cleared 510(K)
K
99
1178
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
2
Cleared 510(K)
K
99
0050
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
2
Cleared 510(K)
K
98
2905
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
2
Cleared 510(K)
K
96
3855
12 URETEROSCOPES/URETERO-RENOSCOPES
2
Cleared 510(K)
K
97
0427
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
2
Cleared 510(K)
K
96
4482
FLEXIBLE URETEROSCOPE
2
Cleared 510(K)
K
96
0323
KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
2
Cleared 510(K)
K
95
1855
ULTRATHIN URETEROSCOPES
2
Cleared 510(K)
K
94
1013
HMT ALEXCOPE
2
Cleared 510(K)
K
94
0464
KARL STORZ URETERO-RENOSCOPE/URETERSCOPE
2
Cleared 510(K)
K
92
5128
THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
2
Cleared 510(K)
K
92
6423
S/2(TM) STOPCOCK
2
Cleared 510(K)
K
92
6004
ENDOSCOPE AND ACCOSSORIES
2
Cleared 510(K)
K
92
3545
BARD 7 FR. FIBER OPTIC ASSEMBLY
2
Cleared 510(K)
K
92
0750
BARD URETEROSCOPE DEFLECTION MODULE
2
Cleared 510(K)
K
91
5458
URETEROSCOPE
2
Cleared 510(K)
K
91
4106
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
2
Cleared 510(K)
K
91
1411
BARD 3000 PLUS URETEROSCOPY SYSTEM
2
Cleared 510(K)
K
90
4793
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
2
Cleared 510(K)
K
90
2773
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
2
Cleared 510(K)
K
90
1214
RIGID URETEROSCOPE
2
Cleared 510(K)
K
90
0813
BARD SHORT RIGID URETEROSCOPE
2
Cleared 510(K)
K
88
4153
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
2
Cleared 510(K)
K
88
3110
BARD URETEROSCOPIC DEVICE
2
Cleared 510(K)
K
88
0802
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
2
Cleared 510(K)
K
88
0801
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
2
Cleared 510(K)
K
87
2282
FLEXIBLE URETEROSCOPE
2
Cleared 510(K)
K
86
2551
FUNS-10, FUNS-11
2
Cleared 510(K)
K
85
2888
OLYMPUS RIGID URETERORENOSCOPE
2
Cleared 510(K)
K
84
4143
OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE
2
Cleared 510(K)
K
81
1535
MODEL FUS-1, FLEXIBLE URETEROSCOPE
2
Cleared 510(K)
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
/
FGB
/
K011325
View Source
MEDIFIX URETEROSCOPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011325
510(k) Type
Traditional
Applicant
MEDIFIX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/25/2001
Days to Decision
85 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
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
K
24
1639
Single-use Video Ureterorenoscope (SVU-220US)
K
24
1598
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)
K
23
3630
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
K
23
2911
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
K
24
0374
Ureterorenoscope System
K
23
3275
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
K
23
1135
Video Ureteroscope System
K
23
1774
CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
K
23
3645
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
K
23
0475
Medical Video Endoscope System
K
22
3097
RenaNav Ureteroscope System
K
23
1878
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
K
23
0200
Single-Use Flexible Ureteroscope
K
22
1158
Single-Use Video Flexible Ureterorenoscope System
K
22
3466
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101
K
22
1515
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
K
22
2737
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K
22
0159
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
K
21
3334
Monarch Platform, Urology
K
21
1686
Flexible Video-Choledo-Cysto-Ureteroscope System
K
21
2458
Flexible Video-Uretero-Renoscope SSU System
K
21
1347
Uretero1 Ureteroscope System
K
21
0579
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
K
20
1897
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
K
20
0369
OES Elite Ureteroscopes and Accessories
K
20
1293
Ureterorenoscope System
K
18
3188
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
K
18
1451
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
K
18
1977
WiScope Digital Endoscope System
K
18
0367
Ureterorenoscope System
K
17
2246
OLYMPUS URF-V2/V2R
K
17
2298
OLYMPUS URF-P6/P6R
K
17
2098
Medical Video Endoscope System
K
17
1076
Medical Video Endoscope System
K
15
3049
LithoVue System
K
14
2556
Flexible Video-Uretero-Choledochoscope System
K
14
1250
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K
13
1369
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K
12
1112
STRYKER VIDEO URETEROSCOPE
K
11
1480
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
K
06
2707
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
K
06
2725
MAXIFLEX-SEMI FLEX SCOPE
K
05
2044
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K
04
3021
STRYKER URETEROSCOPE
K
03
3651
OLYMPUS VIDEO URETEROSCOPE, NTSC
K
03
1278
STRYKER FLEXIBLE URETEROSCOPE
K
02
3358
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
K
01
2758
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
K
01
1849
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
K
01
2951
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
K
01
2925
DUR-8, MODELS DUR-8
K
01
1325
MEDIFIX URETEROSCOPE
K
00
3806
URETEROSCOPES
K
00
0200
CORTEK URETHEROSCOPE
K
99
2527
URETERO-RENOSCOPE
K
99
1178
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
K
99
0050
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
K
98
2905
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
K
96
3855
12 URETEROSCOPES/URETERO-RENOSCOPES
K
97
0427
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
K
96
4482
FLEXIBLE URETEROSCOPE
K
96
0323
KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
K
95
1855
ULTRATHIN URETEROSCOPES
K
94
1013
HMT ALEXCOPE
K
94
0464
KARL STORZ URETERO-RENOSCOPE/URETERSCOPE
K
92
5128
THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K
92
6423
S/2(TM) STOPCOCK
K
92
6004
ENDOSCOPE AND ACCOSSORIES
K
92
3545
BARD 7 FR. FIBER OPTIC ASSEMBLY
K
92
0750
BARD URETEROSCOPE DEFLECTION MODULE
K
91
5458
URETEROSCOPE
K
91
4106
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
K
91
1411
BARD 3000 PLUS URETEROSCOPY SYSTEM
K
90
4793
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
K
90
2773
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
K
90
1214
RIGID URETEROSCOPE
K
90
0813
BARD SHORT RIGID URETEROSCOPE
K
88
4153
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K
88
3110
BARD URETEROSCOPIC DEVICE
K
88
0802
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
K
88
0801
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
K
87
2282
FLEXIBLE URETEROSCOPE
K
86
2551
FUNS-10, FUNS-11
K
85
2888
OLYMPUS RIGID URETERORENOSCOPE
K
84
4143
OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE
K
81
1535
MODEL FUS-1, FLEXIBLE URETEROSCOPE
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
/
FGB
/
K011325
View Source
MEDIFIX URETEROSCOPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011325
510(k) Type
Traditional
Applicant
MEDIFIX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/25/2001
Days to Decision
85 days
Submission Type
Statement