FDA Review Panel · GU

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
8432 Gastroenterology & Urology devices
4251–4275 of 8432
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 174d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · Arthrocare Corp.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 29d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp
ODC · Endoscope Channel Accessory · 26d
Cleared Mar 22, 2001
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
K000724 · Medica S.R.L.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 381d
Cleared Mar 22, 2001
K.E.A.T.
K002154 · Emd Electronic Medical Devices, Corp.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 248d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 92d
Cleared Mar 22, 2001
DAUM DOUBLE-SHOOT BISOPSY GUN
K010037 · Daum GmbH
KNW · Instrument, Biopsy · 77d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Mar 13, 2001
ASPIRE COVERED STENT AND DELIVERY CATHETER
K003173 · Vascular Architects, Inc.
ESW · Prosthesis, Esophageal · 154d
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · Vitrolife Sweden AB
MSB · System And Accessories, Isolated Heart, Transport And Preservation · 353d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339 · Endocare, Inc.
KOD · Catheter, Urological · 30d
Cleared Mar 05, 2001
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp.
EZL · Catheter, Retention Type, Balloon · 88d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · Olympus America, Inc.
MND · Ligator, Esophageal · 264d
Cleared Feb 27, 2001
PARE ENDOSCOPIC SUTURING SYSTEM
K003102 · Pare Surgical, Inc.
OCW · Endoscopic Tissue Approximation Device · 146d
Cleared Feb 22, 2001
URETEROSCOPES
K003806 · Global Endoscopy, Inc.
FGB · Ureteroscope And Accessories, Flexible/rigid · 76d
Cleared Feb 22, 2001
CYSTOSCOPES
K003807 · Global Endoscopy, Inc.
FAJ · Cystoscope And Accessories, Flexible/rigid · 76d
Cleared Feb 16, 2001
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
K001916 · Novartis Nutrition Corp.
KNT · Tubes, Gastrointestinal (and Accessories) · 238d
Cleared Feb 16, 2001
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K002045 · Total Water Treatment Systems, Inc.
FIP · Subsystem, Water Purification · 226d
Cleared Feb 16, 2001
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
K002650 · Bentec Medical, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 175d
Not Cleared Feb 16, 2001
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
DEN000008 · Life Technologies, Inc.
NDS · Media, Culture, Ex Vivo, Tissue And Cell · 59d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 208d
Cleared Feb 13, 2001
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
K002583 · Vidamed, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 179d
Cleared Feb 13, 2001
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
K010340 · Karl Storz Lithotripsy-America, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 8d
Cleared Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
K003529 · Edap Technomed, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 88d
Cleared Feb 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · Rusch Intl.
ESW · Prosthesis, Esophageal · 31d

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All categories 8432 KNT Tubes, Gastrointestinal (and Accessories) 525 FGE Stents, Drains And Dilators For The Biliary Ducts 461 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 331 KNW Instrument, Biopsy 280 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 168 KOD Catheter, Urological 164 KOC Accessories, Blood Circuit, Hemodialysis 146 MSD Catheter, Hemodialysis, Implanted 124 EZL Catheter, Retention Type, Balloon 119 FJI Dialyzer, Capillary, Hollow Fiber 119 FAD Stent, Ureteral 113 FGB Ureteroscope And Accessories, Flexible/rigid 112 FDF Colonoscope And Accessories, Flexible/rigid 111 FIP Subsystem, Water Purification 106 FCG Biopsy Needle 104