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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5373 Gastroenterology & Urology devices
Cleared
Feb 12, 1999
SELF CATH SET/SAFETY CATH
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
168d
Cleared
Feb 12, 1999
WILSON-COOK PANCREATIC WEDGE STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jan 29, 1999
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
207d
Cleared
Jan 27, 1999
CHAIT CECOSTOMY CATHETER
KNT
Tubes, Gastrointestinal (and Accessories)
191d
Cleared
Dec 24, 1998
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
72d
Cleared
Dec 24, 1998
UNIPOLAR OPTICAL BIOPSY FORCEPS
KGE
Forceps, Biopsy, Electric
57d
Cleared
Dec 18, 1998
CORDIS NITINOL STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
290d
Cleared
Dec 15, 1998
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
FAD
Stent, Ureteral
71d
Cleared
Dec 11, 1998
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
GCT
Light Source, Endoscope, Xenon Arc
57d
Cleared
Nov 25, 1998
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
MSD
Catheter, Hemodialysis, Implanted
224d
Cleared
Nov 13, 1998
HEMOCOR HPH 700 HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
71d
Cleared
Nov 10, 1998
DIAPACT CRRT
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
432d
Cleared
Nov 03, 1998
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
MJC
Catheter, Urological (antimicrobial) And Accessories
61d
Cleared
Nov 03, 1998
SMALL VAGINAL/RECTAL ELECTRODE
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
50d
Cleared
Oct 16, 1998
FLEXIMA
FGE
Stents, Drains And Dilators For The Biliary Ducts
88d
Cleared
Oct 05, 1998
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
FGB
Ureteroscope And Accessories, Flexible/rigid
48d
Cleared
Sep 23, 1998
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
30d
Cleared
Sep 22, 1998
STRYKER URETERAL ILLUMINATOR SYSTEM III
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
63d
Cleared
Sep 15, 1998
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
MSE
Hemodialyzer, Re-use, Low Flux
567d
Cleared
Sep 10, 1998
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
LJE
Catheter, Nephrostomy
154d
Cleared
Sep 03, 1998
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
87d
Cleared
Sep 02, 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
86d
Cleared
Aug 27, 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
MSE
Hemodialyzer, Re-use, Low Flux
302d
Cleared
Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
50d
Cleared
Aug 11, 1998
DEROYAL INDUSTRIES, INC. DEFOGGER
OCT
Anti Fog Solution And Accessories, Endoscopy
27d
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