FDA 510(k) Gastroenterology & Urology Devices
FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview
FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.
Common device types:
- GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
- Biliary and pancreatic stents - metal and plastic biliary drainage devices
- Urological devices - ureteral stents, catheters, stone retrieval baskets
- Ablation systems - RFA and cryoablation for GI lesions
- Anorectal devices - manometry systems, hemorrhoid treatment
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8435 Gastroenterology & Urology devices
Cleared
Feb 10, 2000
EASY CARE AND TUBING SETS
FKX
System, Peritoneal, Automatic Delivery
57d
Cleared
Feb 10, 2000
NASOGASTRIC TUBE HOLDER, MODEL 160
KNT
Tubes, Gastrointestinal (and Accessories)
51d
Cleared
Feb 09, 2000
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
162d
Not Cleared
Feb 09, 2000
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
NAM
Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
13d
Cleared
Feb 04, 2000
KARL STORZ AUTOCLAVABLE CAMERA HEAD
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
63d
Cleared
Feb 01, 2000
INTRASTENT DOUBLESTRUT LD
FGE
Stents, Drains And Dilators For The Biliary Ducts
76d
Cleared
Jan 31, 2000
BARD UROFORCE BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
80d
Cleared
Jan 31, 2000
NANMA NON-ADJUSTABLE CONSTRICTION RING
LKY
Device, External Penile Rigidity
75d
Cleared
Jan 31, 2000
NANMA AJUSTABLE CONSTRICTION RING
LKY
Device, External Penile Rigidity
75d
Cleared
Jan 24, 2000
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
FIP
Subsystem, Water Purification
158d
Cleared
Jan 24, 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
FIN
Tank, Holding, Dialysis
133d
Cleared
Jan 24, 2000
MD 420/440/460/470/480/490
FIP
Subsystem, Water Purification
122d
Cleared
Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
MQS
System, Hemodialysis, Access Recirculation Monitoring
90d
Cleared
Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
FFS
Image, Illumination, Fiberoptic, For Endoscope
48d
Cleared
Jan 18, 2000
A-22 HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
169d
Cleared
Jan 18, 2000
AF-180 HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
169d
Cleared
Jan 18, 2000
AF-150 HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
169d
Cleared
Jan 18, 2000
AF-220 HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
169d
Cleared
Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
KNQ
Dilator, Esophageal
76d
Cleared
Jan 14, 2000
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
221d
Cleared
Jan 12, 2000
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
KNT
Tubes, Gastrointestinal (and Accessories)
153d
Cleared
Jan 12, 2000
LEMAITRE BILIARY CATHETER
LQR
Dislodger, Stone, Biliary
134d
Cleared
Jan 10, 2000
AMUKIN D
LIF
Dialyzer Reprocessing System
209d
Cleared
Jan 10, 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
HIR
Perineometer
90d
Cleared
Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
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