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

9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2290 Gastroenterology & Urology devices
1076–1100 of 2290
Cleared Feb 27, 2020
Fusion Quattro Extraction Balloon
K200247 · Wilson-Cook Medical, Inc.
GCA · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection · 27d
Cleared Feb 27, 2020
Disposable Sclerotherapy Needle
K190032 · Hangzhou AGS MedTech Co., Ltd.
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 416d
Not Cleared Feb 25, 2020
iTind System
DEN190020 · Medi-Tate , Ltd.
QKA · Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia · 329d
Cleared Feb 24, 2020
Aquadex FlexFlow System 2.0
K192756 · Chf Solutions, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 147d
Cleared Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
K191474 · Fresenius Medical Care Renal Therapies Group, LLC
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 265d
Cleared Feb 21, 2020
PatCom Single-Use Introducer
K192691 · H&A Mui Enterprises, Inc.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 148d
Cleared Feb 14, 2020
CapsoCam Plus (SV-3) Capsule Endoscopy System
K192662 · CapsoVision, Inc.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 142d
Cleared Feb 07, 2020
Desara One Single Incision Sling System, 1 Pack
K191416 · Caldera Medical, Inc.
PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · 255d
Cleared Jan 31, 2020
Arc Enterocuff
K191330 · Boddingtons Plastics, Ltd.
FDA · Enteroscope And Accessories · 260d
Cleared Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339 · Wilson-Cook Medical, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 155d
Cleared Jan 30, 2020
EndoClot
K191254 · Endoclot Plus Co., Ltd.
PLL · Submucosal Injection Agent · 265d
Cleared Jan 29, 2020
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498 · Cook Incorporated
LJE · Catheter, Nephrostomy · 238d
Cleared Jan 27, 2020
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K191715 · STERIS Corporation
OCU · Endoscopic Storage Cover · 215d
Cleared Jan 22, 2020
HydroPearl Microspheres
K192684 · MicroVention, Inc.
NOY · Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia · 118d
Cleared Jan 22, 2020
Isopure Dry Acid Dissolution System
K191093 · Isopure, Corp.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 272d
Cleared Jan 17, 2020
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K193182 · Olympus Medical Systems Corp.
FDT · Duodenoscope And Accessories, Flexible/rigid · 60d
Cleared Jan 17, 2020
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
K192302 · Covidien, LLC
MPB · Catheter, Hemodialysis, Non-implanted · 147d
Cleared Jan 16, 2020
SherpaPak Lung Preservation System , SherpaPak Liver Transport System
K192869 · Pragonix Technologies
KDN · System, Perfusion, Kidney · 101d
Cleared Jan 16, 2020
INNOVO
K192357 · Atlantic Therapeutics, Ltd.
QAJ · Cutaneous Electrode Stimulator For Urinary Incontinence · 140d
Cleared Jan 03, 2020
Endotics
K190669 · Era Endoscopy S.R.L.
FDF · Colonoscope And Accessories, Flexible/rigid · 294d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · Boston Scientific Corporation
FAD · Stent, Ureteral · 216d
Cleared Jan 02, 2020
Optilume Basic Urological Balloon Dilation Catheter
K191061 · Urotronic, Inc.
KOE · Dilator, Urethral · 255d
Cleared Dec 30, 2019
Disposable Valve Sets
K192258 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
ODC · Endoscope Channel Accessory · 132d
Not Cleared Dec 23, 2019
Mucosal Integrity Conductivity (MI) Test System
DEN180067 · Diversatek Healthcare, Inc.
QIS · Esophageal, Mucosal, Electrical Characterization · 371d
Cleared Dec 20, 2019
UroLift System (UL400)
K193269 · Neotract, Inc.
PEW · Implantable Transprostatic Tissue Retractor System · 24d

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All categories 2290 FGE Stents, Drains And Dilators For The Biliary Ducts 155 KNT Tubes, Gastrointestinal (and Accessories) 108 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 72 FGB Ureteroscope And Accessories, Flexible/rigid 70 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 66 PKL Hemostatic Metal Clip For The Gi Tract 49 FED Endoscopic Access Overtube, Gastroenterology-urology 48 ODC Endoscope Channel Accessory 47 FAD Stent, Ureteral 45 FAJ Cystoscope And Accessories, Flexible/rigid 44 OCX Endoscopic Irrigation/suction System 44 EZL Catheter, Retention Type, Balloon 43 EZD Catheter, Straight 43 FDS Gastroscope And Accessories, Flexible/rigid 39 FDF Colonoscope And Accessories, Flexible/rigid 39