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
8429 Gastroenterology & Urology devices
4051–4075 of 8429
Cleared Feb 06, 2002
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K014169 · Bob J. Johnson & Assoc., Inc.
FIP · Subsystem, Water Purification · 49d
Cleared Feb 05, 2002
TRAPSYSTEM SET
K013692 · H.S. Hospital Service S.R.L.
KNW · Instrument, Biopsy · 90d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082 · Endocare, Inc.
LKY · Device, External Penile Rigidity · 26d
Cleared Feb 04, 2002
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
K012502 · Janin Group, Inc.
FJS · Catheter, Peritoneal, Long-term Indwelling · 185d
Cleared Feb 04, 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 90d
Cleared Jan 25, 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575 · Organ Recovery Systems, Inc.
KDN · System, Perfusion, Kidney · 88d
Cleared Jan 18, 2002
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
K010549 · Medi-Globe Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 326d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
K012328 · Di-Chem, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 179d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
K012547 · Di-Chem, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 164d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Jan 17, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K014136 · Sulzer Intratherapeutics, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 31d
Cleared Jan 15, 2002
PRISMASATE
K013448 · Gambro Renal Products
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 90d
Cleared Jan 14, 2002
INCARE ADVANCE
K013483 · Hollister, Inc.
KOD · Catheter, Urological · 87d
Cleared Jan 14, 2002
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
K014205 · Medtronic Ave, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 24d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · Vygon Corp.
FPD · Tube, Feeding · 445d
Cleared Jan 08, 2002
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
K011190 · Surx, Inc.
MUK · Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue · 264d
Cleared Jan 08, 2002
BICART
K013724 · Gambro Renal Products
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 60d
Cleared Jan 07, 2002
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS
K011537 · Dynamic Technology Corp.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 234d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345 · Hollister, Inc.
KOD · Catheter, Urological · 90d
Cleared Jan 07, 2002
SHARGHP A.V. FISTULA NEEDLE SET
K013384 · Shargh Pharmaceutical Co., Inc.
FIE · Needle, Fistula · 87d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 33d
Cleared Jan 04, 2002
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
K013174 · Porges S.A.
EZL · Catheter, Retention Type, Balloon · 102d
Cleared Dec 20, 2001
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
K012660 · Gimmi GmbH
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 129d
Cleared Dec 20, 2001
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
K013172 · Porges S.A.
EZL · Catheter, Retention Type, Balloon · 87d
Cleared Dec 19, 2001
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 90d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 8429 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 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104