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
8427 Gastroenterology & Urology devices
3901–3925 of 8427
Cleared Oct 30, 2002
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
K022536 · Fresenius Medical Care
KOC · Accessories, Blood Circuit, Hemodialysis · 90d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 161d
Cleared Oct 25, 2002
HORIZONS REUSABLE HOT BIOPSY FORCEPS
K022243 · Horizons Intl. Corp.
KGE · Forceps, Biopsy, Electric · 105d
Cleared Oct 25, 2002
HORIZONS REUSABLE POLYPECTOMY SNARES
K022268 · Horizons Intl. Corp.
FDI · Snare, Flexible · 102d
Cleared Oct 25, 2002
COOK INJECTION NEEDLE
K022484 · Cook Urological, Inc.
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 88d
Cleared Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Oct 25, 2002
INFUSION CATHETER EXTENSION SET
K023224 · Chf Solutions, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 28d
Cleared Oct 21, 2002
DIASOL-ADDITIVES
K020231 · Diasol, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 271d
Cleared Oct 21, 2002
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
K022391 · Organ Recovery Systems, Inc.
KDN · System, Perfusion, Kidney · 90d
Cleared Oct 21, 2002
NXSTAGE PREMIXED DIALYSATE
K022913 · Nxstage Medical, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 48d
Cleared Oct 17, 2002
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
K013921 · Porges S.A.
FAD · Stent, Ureteral · 324d
Cleared Oct 17, 2002
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
K021856 · Porges S.A.
EYB · Catheter, Ureteral, Gastro-urology · 133d
Cleared Oct 17, 2002
WILSON-COOK CYSTOTOME
K022595 · Wilson-Cook Medical, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 73d
Cleared Oct 11, 2002
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL
K020936 · Medcomp
MSD · Catheter, Hemodialysis, Implanted · 203d
Cleared Oct 11, 2002
ENCIRCLE LOCALIZATION DEVICE
K022286 · Vivant Medical, Inc.
KNW · Instrument, Biopsy · 88d
Cleared Oct 11, 2002
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
K022620 · Spire Biomedical, Inc.
FKA · Dilator, Vessel · 65d
Cleared Oct 09, 2002
CLEAR-IT ANTI-FOG, MODEL PS003
K022826 · Preservation Solutions, Inc.
OCT · Anti Fog Solution And Accessories, Endoscopy · 44d
Cleared Oct 01, 2002
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
K021142 · Fortune Medical Instrument Corp.
EZL · Catheter, Retention Type, Balloon · 175d
Cleared Sep 27, 2002
DAYTRIPPER DIALYSATE WARMER
K020542 · Stickman Industries, Inc.
MLW · Warmer, Peritoneal Dialysate · 220d
Cleared Sep 27, 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
K021266 · Ethicon Endo-Surgery, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 158d
Cleared Sep 23, 2002
NAFD 100
K020848 · Neomatrix, LLC
KNW · Instrument, Biopsy · 192d
Cleared Sep 23, 2002
TUBING, DIALYSATE (AND CONNECTOR)
K022068 · Molded Products, Inc.
FID · Tubing, Dialysate · 90d
Cleared Sep 23, 2002
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K022287 · 3t Medical Systems, LLC
EZL · Catheter, Retention Type, Balloon · 70d
Cleared Sep 23, 2002
MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
K022879 · Sanarus Medical, Inc.
KNW · Instrument, Biopsy · 24d
Cleared Sep 18, 2002
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
K020255 · Richard Wolf Medical Instruments Corp.
ODA · Endoscopic Central Control Unit · 237d

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All categories 8427 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 145 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