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
8399 Gastroenterology & Urology devices
Cleared
Dec 22, 2010
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
103d
Cleared
Dec 22, 2010
RESOLUTION II CLIP
PKL
Hemostatic Metal Clip For The Gi Tract
89d
Cleared
Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
62d
Cleared
Dec 21, 2010
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A
MPB
Catheter, Hemodialysis, Non-implanted
307d
Cleared
Dec 21, 2010
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
186d
Cleared
Dec 16, 2010
ENDO FLIP
FFX
System, Gastrointestinal Motility (electrical)
132d
Cleared
Dec 13, 2010
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
FPD
Tube, Feeding
276d
Cleared
Dec 08, 2010
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
FIN
Tank, Holding, Dialysis
379d
Cleared
Dec 02, 2010
ENVIEW (TM)
OCV
Endoscope Holder
121d
Cleared
Dec 01, 2010
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
PKL
Hemostatic Metal Clip For The Gi Tract
194d
Cleared
Dec 01, 2010
VITALA CONTINENCE CONTROL DEVICE
EZQ
Pouch, Colostomy
89d
Cleared
Dec 01, 2010
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FFT
Electrode, Ph, Stomach
89d
Cleared
Nov 26, 2010
FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
84d
Cleared
Nov 22, 2010
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
FGE
Stents, Drains And Dilators For The Biliary Ducts
81d
Cleared
Nov 19, 2010
UNIVERSAL IRRIGATION SOLUTION HYBRID
OCX
Endoscopic Irrigation/suction System
51d
Cleared
Nov 19, 2010
SPECTRA OPTIA R APHERESIS SYSTEM
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
31d
Cleared
Nov 18, 2010
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
121d
Cleared
Nov 08, 2010
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
ODC
Endoscope Channel Accessory
61d
Cleared
Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
KOD
Catheter, Urological
64d
Cleared
Nov 04, 2010
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
ODC
Endoscope Channel Accessory
72d
Cleared
Nov 03, 2010
CLEARFLUX DIALYZER REPROCESSING SYSTEM
LIF
Dialyzer Reprocessing System
544d
Cleared
Nov 03, 2010
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
264d
Cleared
Oct 26, 2010
PHTIP DISPOSABLE ISFET CATHETER
FFX
System, Gastrointestinal Motility (electrical)
29d
Cleared
Oct 23, 2010
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
388d
Cleared
Oct 21, 2010
URGENT PC STIMULATOR
NAM
Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
112d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices