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
4101–4125 of 8431
Cleared Nov 09, 2001
SE-300 VACUUM THERAPY SYSTEM
K012639 · Vts, Inc.
LKY · Device, External Penile Rigidity · 88d
Cleared Nov 09, 2001
SE-100 VACUUM ERECTION DEVICE
K012662 · Vts, Inc.
LKY · Device, External Penile Rigidity · 88d
Cleared Nov 09, 2001
BOSS 2000-3 VACUUM ERECTION DEVICE
K012670 · Pos-T-Vac, Inc.
LKY · Device, External Penile Rigidity · 88d
Cleared Nov 09, 2001
BOSS-2000-2 VACUUM ERECTION DEVICE
K012672 · Pos-T-Vac, Inc.
LKY · Device, External Penile Rigidity · 88d
Cleared Nov 09, 2001
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
K012951 · Circon Video
FGB · Ureteroscope And Accessories, Flexible/rigid · 66d
Cleared Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc.
MNW · Analyzer, Body Composition · 162d
Cleared Nov 07, 2001
REPROCESSED ENDOSCOPIC TROCAR
K012578 · Sterilmed, Inc.
NLM · Laparoscope, General & Plastic Surgery, Reprocessed · 90d
Cleared Nov 07, 2001
DUR-8, MODELS DUR-8
K012925 · Circon Video
FGB · Ureteroscope And Accessories, Flexible/rigid · 68d
Cleared Nov 02, 2001
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · Zevex, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 115d
Cleared Nov 02, 2001
VARICES INJECTION NEEDLE
K012977 · Endo-Therapeutics, Inc.
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 58d
Cleared Nov 01, 2001
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products
FIP · Subsystem, Water Purification · 315d
Cleared Oct 31, 2001
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
K011221 · Gambro Renal Products
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 194d
Cleared Oct 31, 2001
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
K011916 · Horizon Medical Products, Inc.
MSD · Catheter, Hemodialysis, Implanted · 133d
Cleared Oct 26, 2001
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
K012628 · Gynecare Center
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 74d
Cleared Oct 26, 2001
SPARC SLING SYSTEM
K013355 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 16d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
K012822 · Boston Scientific Scimed, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 62d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp
FCG · Biopsy Needle · 58d
Cleared Oct 19, 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 74d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 29d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · Boston Scientific Corp
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 29d
Cleared Oct 19, 2001
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154 · Dentsleeve Pty., Ltd.
FFX · System, Gastrointestinal Motility (electrical) · 29d
Cleared Oct 19, 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162 · Medcomp
KNT · Tubes, Gastrointestinal (and Accessories) · 28d
Cleared Oct 19, 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · Wilson-Cook Medical, Inc.
FCG · Biopsy Needle · 9d
Cleared Oct 17, 2001
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K012265 · Circon Video
FCW · Light Source, Fiberoptic, Routine · 90d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · KARL STORZ Endoscopy-America, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 75d

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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