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

9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5364 Gastroenterology & Urology devices
1001–1025 of 5364
Cleared Sep 24, 2020
EndoGI S-Path Biliary Stent System
K202477 · Endo GI Medical
FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d
Cleared Sep 21, 2020
Optiflux F180NR Dialyzer
K192707 · Fresenius Medical Care Renal Therapies Group, LLC
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 360d
Cleared Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
K201207 · Fresenius Medical Care Renal Therapies Group, LLC
KOC · Accessories, Blood Circuit, Hemodialysis · 136d
Cleared Sep 17, 2020
GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
K201686 · Ethicon, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 87d
Cleared Sep 16, 2020
Tulsa-Pro System
K202286 · Profound Medical, Inc.
PLP · High Intensity Ultrasound System For Prostate Tissue Ablation · 35d
Cleared Sep 12, 2020
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · Shinva Ande Healthcare Apparatus Co., Ltd.
PNR · Enteral Syringes With Enteral Specific Connectors · 257d
Cleared Sep 11, 2020
AMICUS Separator System
K200530 · Fresenius Kabi AG
GKT · Separator, Automated, Blood Cell, Diagnostic · 193d
Cleared Sep 03, 2020
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
K202176 · Medical Components, Inc. (dba MedComp)
MSD · Catheter, Hemodialysis, Implanted · 30d
Cleared Sep 03, 2020
Delta III Lithotripter
K201074 · Dornier Medtech America, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 134d
Cleared Sep 02, 2020
SmartHDM-510 System
K201765 · Mesa Laboratories, Inc.
FIZ · Meter, Conductivity, Non-remote · 65d
Cleared Sep 02, 2020
Endofresh Digestive Endoscopy System
K192704 · Huizhou Xzing Technology Co., Ltd.
FDS · Gastroscope And Accessories, Flexible/rigid · 341d
Cleared Sep 01, 2020
Image1 S CCU, Image1 S 4U Camera Head
K201135 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 126d
Cleared Sep 01, 2020
Resolution 360™ ULTRA Clip
K193424 · Boston Scientific Corporation
PKL · Hemostatic Metal Clip For The Gi Tract · 266d
Cleared Aug 28, 2020
Temno Elite Biopsy System
K201166 · Merit Medical Systems, Inc.
KNW · Instrument, Biopsy · 119d
Cleared Aug 28, 2020
OES Elite Ureteroscopes and Accessories
K200369 · Olympus Winter & Ibe GmbH
FGB · Ureteroscope And Accessories, Flexible/rigid · 196d
Cleared Aug 28, 2020
DIMI RRT System
K193005 · Dialco Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 305d
Not Cleared Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
DEN190042 · Baxter Healthcare Corporation
QAX · Hemodialyzer With Expanded Solute Removal Profile · 347d
Cleared Aug 27, 2020
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
OCT · Anti Fog Solution And Accessories, Endoscopy · 512d
Cleared Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · Boston Scientific Corporation
MQR · Stent, Colonic, Metallic, Expandable · 109d
Cleared Aug 07, 2020
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
K201244 · Transmed7, LLC
KNW · Instrument, Biopsy · 91d
Cleared Aug 03, 2020
Vesco Medical Extension Feeding Set
K192991 · Vesco Medical, LLC
PIF · Gastrointestinal Tubes With Enteral Specific Connectors · 283d
Cleared Jul 31, 2020
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
K201837 · Neotract, Inc.
PEW · Implantable Transprostatic Tissue Retractor System · 29d
Cleared Jul 31, 2020
Cyber Blade
K192499 · SIDAM S.r.l.
GCJ · Laparoscope, General & Plastic Surgery · 324d
Cleared Jul 30, 2020
SpeediCath Soft
K200142 · Coloplast
GBM · Catheter, Urethral · 190d
Cleared Jul 30, 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082 · Mps Medical, Inc.
PIF · Gastrointestinal Tubes With Enteral Specific Connectors · 197d

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All categories 5364 FGE Stents, Drains And Dilators For The Biliary Ducts 314 KNT Tubes, Gastrointestinal (and Accessories) 301 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 217 KOD Catheter, Urological 128 KNW Instrument, Biopsy 122 KOC Accessories, Blood Circuit, Hemodialysis 121 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 116 FJI Dialyzer, Capillary, Hollow Fiber 96 FAD Stent, Ureteral 94 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 91 FGB Ureteroscope And Accessories, Flexible/rigid 89 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 81 FDF Colonoscope And Accessories, Flexible/rigid 71 EXB Collector, Ostomy 68 FED Endoscopic Access Overtube, Gastroenterology-urology 67