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
8431 Gastroenterology & Urology devices
4176–4200 of 8431
Cleared Aug 02, 2001
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · Gambro Renal Products
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 90d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 99d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · Cordis Europa, N.V.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Aug 01, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012066 · Sulzer Intratherapeutics, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012090 · Cordis, A Johnson & Johnson Co.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d
Not Cleared Aug 01, 2001
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002 · Given Imaging , Ltd.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 51d
Cleared Jul 31, 2001
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K003580 · Unisensor AG
FFX · System, Gastrointestinal Motility (electrical) · 253d
Cleared Jul 31, 2001
R STENT BILIARY ENDOPROSTHESIS
K010107 · Orbus Medical Technologies
FGE · Stents, Drains And Dilators For The Biliary Ducts · 200d
Cleared Jul 25, 2001
TACKER, MODEL R65-933
K003949 · A & A Medical, Inc.
OCW · Endoscopic Tissue Approximation Device · 216d
Cleared Jul 25, 2001
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · Applied Medical Resources Corp.
EZL · Catheter, Retention Type, Balloon · 204d
Cleared Jul 25, 2001
MEDIFIX URETEROSCOPE
K011325 · Medifix, Inc.
FGB · Ureteroscope And Accessories, Flexible/rigid · 85d
Cleared Jul 24, 2001
VACUUM ASSISTED CORE BIOPSY DEVICE
K010400 · Promex, Inc.
KNW · Instrument, Biopsy · 162d
Cleared Jul 18, 2001
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
K011206 · Parallax Medical, Inc.
KNW · Instrument, Biopsy · 90d
Cleared Jul 18, 2001
UROLOGICAL CATHETER
K011552 · Apogee Medical, Inc.
GBM · Catheter, Urethral · 61d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Jul 17, 2001
MESH URETERAL STENT
K011264 · Applied Medical Resources Corp.
FAD · Stent, Ureteral · 83d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp
KOD · Catheter, Urological · 18d
Cleared Jul 12, 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · Denver Biomedical, Inc.
KPM · Shunt, Peritoneal · 28d
Cleared Jul 11, 2001
RECTOSIGHT RS300-04
K011825 · Sightline Technologies , Ltd.
FER · Anoscope And Accessories · 30d
Cleared Jul 09, 2001
GASTRIC SUCTION AND DRAINAGE CATHETER
K002838 · Bioenterics Corp.
KNT · Tubes, Gastrointestinal (and Accessories) · 300d
Cleared Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787 · Vidamed, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 28d
Cleared Jul 03, 2001
BODYSTAT
K002835 · Bodystat , Ltd.
MNW · Analyzer, Body Composition · 294d
Cleared Jun 27, 2001
EASYBELL
K011075 · Biopsybell S.A.S.
FCG · Biopsy Needle · 79d
Cleared Jun 22, 2001
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · Sandhill Scientific, Inc.
FFX · System, Gastrointestinal Motility (electrical) · 318d

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All categories 8431 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 146 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 FCG Biopsy Needle 104