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
2325 Gastroenterology & Urology devices
1476–1500 of 2325
Cleared Jan 18, 2018
Pelvifine Pelvic Muscle Trainer
K163288 · Shenzhen Konmed Technology Co., Ltd.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 422d
Cleared Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
K171207 · Fujifilm Medical Systems U.S.A, Inc.
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 261d
Cleared Jan 10, 2018
Swiss LithoClast Trilogy
K173234 · E.M.S Electro Medical Systems S.A
FEO · Lithotriptor, Ultrasonic · 97d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
K172929 · Boston Scientific Corporation
LJE · Catheter, Nephrostomy · 107d
Cleared Jan 10, 2018
Instalief
K172358 · Privi Medical Pte, Ltd.
LKX · Device, Thermal, Hemorrhoids · 160d
Cleared Jan 08, 2018
invendoscopy E210 System
K173085 · Invendo Medical GmbH
FDF · Colonoscope And Accessories, Flexible/rigid · 101d
Cleared Jan 05, 2018
AquaShield System CO2- Fujifilm
K173650 · United States Endoscopy Group, Inc.
FEQ · Pump, Air, Non-manual, For Endoscope · 38d
Cleared Jan 05, 2018
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel
FIP · Subsystem, Water Purification · 267d
Cleared Dec 29, 2017
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · Wilson-Cook Medical, Inc.
FDX · Endoscopic Cytology Brush · 213d
Cleared Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
K172565 · Boston Scientific Corporation
PWJ · Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence · 117d
Cleared Dec 15, 2017
Strange Bile Duct Stone Exploration Set
K173687 · Cook Incorporated
LQR · Dislodger, Stone, Biliary · 14d
Cleared Dec 13, 2017
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
K172217 · Cook Incorporated
FED · Endoscopic Access Overtube, Gastroenterology-urology · 142d
Cleared Dec 12, 2017
Wittich Nitinol Stone Basket
K170898 · Cook Incorporated
LQR · Dislodger, Stone, Biliary · 260d
Cleared Dec 07, 2017
Single Use Electrosurgical Snare SD-400
K172734 · Olympus Medical Systems Corp.
FDI · Snare, Flexible · 87d
Cleared Nov 27, 2017
Single Use Retrieval Nitinol Basket V
K170811 · Olympus Medical Systems Corp.
LQR · Dislodger, Stone, Biliary · 255d
Cleared Nov 22, 2017
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated
GBM · Catheter, Urethral · 117d
Cleared Nov 17, 2017
Gastric Sizing Balloon Catheter
K173355 · Cook Incorporated
KNT · Tubes, Gastrointestinal (and Accessories) · 23d
Cleared Nov 17, 2017
Single Use Electrosurgical knife
K171158 · Olympus Medical Systems Corp.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 211d
Cleared Nov 07, 2017
NCompass Nitinol Stone Extractors
K173009 · Cook Incorporated
LQR · Dislodger, Stone, Biliary · 41d
Cleared Oct 19, 2017
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
K172527 · Cook Incorporated
LJE · Catheter, Nephrostomy · 59d
Cleared Oct 17, 2017
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
K172817 · Olympus Medical Systems Corp.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 29d
Cleared Oct 13, 2017
Single Use Hot Biopsy Forceps FD-231
K171916 · Olympus Medical Systems Corp.
KGE · Forceps, Biopsy, Electric · 109d
Cleared Oct 13, 2017
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
K171548 · Wilson-Cook Medical, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 140d
Cleared Oct 05, 2017
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
K172558 · Stryker Corporation
KNW · Instrument, Biopsy · 42d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · Boston Scientific Corporation
FGE · Stents, Drains And Dilators For The Biliary Ducts · 44d

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All categories 2325 FGE Stents, Drains And Dilators For The Biliary Ducts 155 KNT Tubes, Gastrointestinal (and Accessories) 109 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 74 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 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 KNW Instrument, Biopsy 39 FDS Gastroscope And Accessories, Flexible/rigid 39