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
1076–1100 of 5364
Cleared Mar 31, 2020
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K200556 · H R Pharmaceuticals, Inc.
EZL · Catheter, Retention Type, Balloon · 28d
Cleared Mar 27, 2020
Single Use Grasping Forceps
K191900 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
OCZ · Endoscopic Grasping/cutting Instrument, Non-powered · 255d
Cleared Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905 · Creo Medical, Ltd.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 156d
Cleared Mar 13, 2020
PrisMax System Version 3
K193482 · Baxter Healthcare Corporation
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 87d
Cleared Mar 13, 2020
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
K193325 · Prosys International, Ltd.
KNT · Tubes, Gastrointestinal (and Accessories) · 102d
Cleared Mar 12, 2020
AMT Suture Delivery System
K193612 · Applied Medical Technology, Inc.
KGC · Tube, Gastro-enterostomy · 77d
Cleared Mar 05, 2020
Instinct Plus Endoscopic Clipping Device
K192697 · Cook Endoscopy
PKL · Hemostatic Metal Clip For The Gi Tract · 161d
Cleared Mar 05, 2020
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
K190527 · C. R. Bard
MSD · Catheter, Hemodialysis, Implanted · 367d
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

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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