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
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
K
24
2173
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
2
Cleared 510(K)
K
24
3091
Over-tube (TR-1108A)
2
Cleared 510(K)
K
24
0167
Single-use Ureteral Access Sheath
2
Cleared 510(K)
K
24
1181
Disposable Ureteral Guide Sheath
2
Cleared 510(K)
K
24
0853
Pathfinder® CR System
2
Cleared 510(K)
K
23
3472
CVAC Aspiration System + CVAC Image Processor
2
Cleared 510(K)
K
23
0752
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
2
Cleared 510(K)
K
23
0748
Disposable Ureteral Access Sheath
2
Cleared 510(K)
K
23
0801
Pathfinder Endoscope Overtube with Balloon Device
2
Cleared 510(K)
K
22
0065
Single Use Ureteral Access Sheath
2
Cleared 510(K)
K
20
0770
Mini PCNL-System
2
Cleared 510(K)
K
21
1301
Pathfinder Endoscope Overtube
2
Cleared 510(K)
K
20
3165
Disposable Ureteral Access Sheath
2
Cleared 510(K)
K
20
3119
ClearPetra Suction-Evacuation Sheath
2
Cleared 510(K)
K
20
1815
Dornier MAGELLAN Ureteral Access Sheath
2
Cleared 510(K)
K
20
0419
Kalera Vacuum Aspiration Catheter (K-VAC)
2
Cleared 510(K)
K
19
2691
PatCom Single-Use Introducer
2
Cleared 510(K)
K
19
1415
Pathfinder Endoscope Overtube
2
Cleared 510(K)
K
19
1067
Arc Endocuff Glide AEG110 & AEG120
2
Cleared 510(K)
K
18
2403
Peel-Away Introducer
2
Cleared 510(K)
K
18
2520
Flexible Overtube
2
Cleared 510(K)
K
19
0030
Embrella Endoscopic Distal Attachment
2
Cleared 510(K)
K
18
1811
ReTrace Ureteral Access Sheath
2
Cleared 510(K)
K
17
3400
ORISE Tissue Retractor System
2
Cleared 510(K)
K
17
1208
Trans-anal Introducer
2
Cleared 510(K)
K
17
2575
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
2
Cleared 510(K)
K
17
2217
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
2
Cleared 510(K)
K
16
2205
Arc EndoCuff and Arc EndoCuff Vision
2
Cleared 510(K)
K
16
1110
ClearPetra Suction-Evacuation Sheath
2
Cleared 510(K)
K
16
0846
AmplifEYE
2
Cleared 510(K)
K
16
0861
Proxis Ureteral Access Sheath
2
Cleared 510(K)
K
15
1084
Well Lead Ureteral Access Sheath
2
Cleared 510(K)
K
15
1801
Arc Endocuff Vision
2
Cleared 510(K)
K
15
0083
Sidecar External Working Channel
2
Cleared 510(K)
K
14
0523
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
2
Cleared 510(K)
K
14
0323
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
2
Cleared 510(K)
K
13
1598
ANAL RECTAL OVERTUBE
2
Cleared 510(K)
K
13
3359
ENDORINGS
2
Cleared 510(K)
K
12
3013
ENDOSCOPIC INTRODUCER
2
Cleared 510(K)
K
12
3675
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
2
Cleared 510(K)
K
12
2649
NAVIGATOR HD URETERAL ACCESS SHEATH SET
2
Cleared 510(K)
K
12
2270
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
2
Cleared 510(K)
K
12
0126
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
2
Cleared 510(K)
K
12
2565
ARC ENDOCUFF
2
Cleared 510(K)
K
11
0531
ENDOFLIP ECD
2
Cleared 510(K)
K
10
2485
RE-TRACE URETERAL ACCESS SHEATH
2
Cleared 510(K)
K
08
2102
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
2
Cleared 510(K)
K
10
0081
ENTEROSCOPY OVERTUBE, MODEL 00712140
2
Cleared 510(K)
K
09
2221
COLONIC SPLINTING OVERTUBE, MODEL 00711145
2
Cleared 510(K)
K
09
2156
CAD 12, COLONOSCOPY ASSIST DEVICE
2
Cleared 510(K)
K
09
1773
FUJINON STERILE OVERTUBES
2
Cleared 510(K)
K
08
2589
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
2
Cleared 510(K)
K
08
0050
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
2
Cleared 510(K)
K
07
2405
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
06
2805
MODIFICATION TO ENDO-EASE
2
Cleared 510(K)
K
06
1324
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
2
Cleared 510(K)
K
06
1216
USGI TRANSPORT ENDOSCOPIC GUIDE
2
Cleared 510(K)
K
05
2084
ENDO-EASE ENDOSCOPIC OVERTUBE
2
Cleared 510(K)
K
05
1919
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
2
Cleared 510(K)
K
05
1504
SPYSCOPE ACCESS AND DELIVERY CATHETER
2
Cleared 510(K)
K
04
3418
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
2
Cleared 510(K)
K
05
0253
USGI SHAPELOCK ENDOSCOPIC GUIDE
2
Cleared 510(K)
K
04
0836
DISPOSABLE OVERTUBE
2
Cleared 510(K)
K
03
3954
SHAPE LOCKING ENDOSCOPIC OVERTUBE
2
Cleared 510(K)
K
03
3778
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
2
Cleared 510(K)
K
02
3902
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
2
Cleared 510(K)
K
03
0956
NAVIGATOR URETERAL ACCESS SHEATH SET
2
Cleared 510(K)
K
03
0642
DEFLECTING URETERAL ACCESS SHEATH
2
Cleared 510(K)
K
03
0438
BARD AQUAGUIDE URETERAL CONDUIT
2
Cleared 510(K)
K
02
2686
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
2
Cleared 510(K)
K
00
2018
NDO SURGICAL SURGICAL OVERTUBE
2
Cleared 510(K)
K
99
3650
URETERAL ACCESS SHEATH SET - NEW MODELS
2
Cleared 510(K)
K
99
0775
URETERAL ACCESS SHEATH SET
2
Cleared 510(K)
K
98
3415
DELIVERY SHEATH
2
Cleared 510(K)
K
97
3500
BARD ENDOSCOPIC OVERTUBE (#000307)
2
Cleared 510(K)
K
97
2781
OT-1
2
Cleared 510(K)
K
94
2573
COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
2
Cleared 510(K)
K
94
2044
BARD ENDOSCOPIC OVERTUBE
2
Cleared 510(K)
K
92
1120
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
2
Cleared 510(K)
K
91
2265
MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
2
Cleared 510(K)
K
90
3842
ST-E1 OVERTUBE
2
Cleared 510(K)
K
89
6680
PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
2
Cleared 510(K)
K
89
0629
ESOPHAGEAL OVERTUBE
2
Cleared 510(K)
K
84
1258
FOREIGN BODY PROTECTOR
2
Cleared 510(K)
K
83
3268
ENDOSCOPIC OVERTUBE
2
Cleared 510(K)
K
83
0247
SPLIT COLON STIFFENING TUBE
2
Cleared 510(K)
K
81
3325
KEY MED FOREIGN BODY REMOVAL TUBE
2
Cleared 510(K)
K
81
0180
WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
2
Cleared 510(K)
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
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 13 December 2024 at 11:05 pm
GU
/
subpart-b—diagnostic-devices
/
FED
/
K140523
View Source
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140523
510(k) Type
Special
Applicant
COLOPLAST A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/2014
Days to Decision
142 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
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
K
24
2173
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
K
24
3091
Over-tube (TR-1108A)
K
24
0167
Single-use Ureteral Access Sheath
K
24
1181
Disposable Ureteral Guide Sheath
K
24
0853
Pathfinder® CR System
K
23
3472
CVAC Aspiration System + CVAC Image Processor
K
23
0752
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
K
23
0748
Disposable Ureteral Access Sheath
K
23
0801
Pathfinder Endoscope Overtube with Balloon Device
K
22
0065
Single Use Ureteral Access Sheath
K
20
0770
Mini PCNL-System
K
21
1301
Pathfinder Endoscope Overtube
K
20
3165
Disposable Ureteral Access Sheath
K
20
3119
ClearPetra Suction-Evacuation Sheath
K
20
1815
Dornier MAGELLAN Ureteral Access Sheath
K
20
0419
Kalera Vacuum Aspiration Catheter (K-VAC)
K
19
2691
PatCom Single-Use Introducer
K
19
1415
Pathfinder Endoscope Overtube
K
19
1067
Arc Endocuff Glide AEG110 & AEG120
K
18
2403
Peel-Away Introducer
K
18
2520
Flexible Overtube
K
19
0030
Embrella Endoscopic Distal Attachment
K
18
1811
ReTrace Ureteral Access Sheath
K
17
3400
ORISE Tissue Retractor System
K
17
1208
Trans-anal Introducer
K
17
2575
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K
17
2217
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
K
16
2205
Arc EndoCuff and Arc EndoCuff Vision
K
16
1110
ClearPetra Suction-Evacuation Sheath
K
16
0846
AmplifEYE
K
16
0861
Proxis Ureteral Access Sheath
K
15
1084
Well Lead Ureteral Access Sheath
K
15
1801
Arc Endocuff Vision
K
15
0083
Sidecar External Working Channel
K
14
0523
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
K
14
0323
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
K
13
1598
ANAL RECTAL OVERTUBE
K
13
3359
ENDORINGS
K
12
3013
ENDOSCOPIC INTRODUCER
K
12
3675
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
K
12
2649
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K
12
2270
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
K
12
0126
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
K
12
2565
ARC ENDOCUFF
K
11
0531
ENDOFLIP ECD
K
10
2485
RE-TRACE URETERAL ACCESS SHEATH
K
08
2102
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
K
10
0081
ENTEROSCOPY OVERTUBE, MODEL 00712140
K
09
2221
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K
09
2156
CAD 12, COLONOSCOPY ASSIST DEVICE
K
09
1773
FUJINON STERILE OVERTUBES
K
08
2589
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
K
08
0050
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
K
07
2405
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
K
06
2805
MODIFICATION TO ENDO-EASE
K
06
1324
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
K
06
1216
USGI TRANSPORT ENDOSCOPIC GUIDE
K
05
2084
ENDO-EASE ENDOSCOPIC OVERTUBE
K
05
1919
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
K
05
1504
SPYSCOPE ACCESS AND DELIVERY CATHETER
K
04
3418
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K
05
0253
USGI SHAPELOCK ENDOSCOPIC GUIDE
K
04
0836
DISPOSABLE OVERTUBE
K
03
3954
SHAPE LOCKING ENDOSCOPIC OVERTUBE
K
03
3778
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
K
02
3902
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
K
03
0956
NAVIGATOR URETERAL ACCESS SHEATH SET
K
03
0642
DEFLECTING URETERAL ACCESS SHEATH
K
03
0438
BARD AQUAGUIDE URETERAL CONDUIT
K
02
2686
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
K
00
2018
NDO SURGICAL SURGICAL OVERTUBE
K
99
3650
URETERAL ACCESS SHEATH SET - NEW MODELS
K
99
0775
URETERAL ACCESS SHEATH SET
K
98
3415
DELIVERY SHEATH
K
97
3500
BARD ENDOSCOPIC OVERTUBE (#000307)
K
97
2781
OT-1
K
94
2573
COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
K
94
2044
BARD ENDOSCOPIC OVERTUBE
K
92
1120
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
K
91
2265
MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
K
90
3842
ST-E1 OVERTUBE
K
89
6680
PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
K
89
0629
ESOPHAGEAL OVERTUBE
K
84
1258
FOREIGN BODY PROTECTOR
K
83
3268
ENDOSCOPIC OVERTUBE
K
83
0247
SPLIT COLON STIFFENING TUBE
K
81
3325
KEY MED FOREIGN BODY REMOVAL TUBE
K
81
0180
WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
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
/
FED
/
K140523
View Source
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140523
510(k) Type
Special
Applicant
COLOPLAST A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/2014
Days to Decision
142 days
Submission Type
Summary