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
5373 Gastroenterology & Urology devices
2826–2850 of 5373
Cleared Aug 12, 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
K971977 · KARL STORZ Endoscopy-America, Inc.
FBN · Choledochoscope And Accessories, Flexible/rigid · 75d
Cleared Aug 12, 1997
KARL STORZ MODEL 203020 20 EQUIMAT
K971982 · KARL STORZ Endoscopy-America, Inc.
LJH · System, Irrigation, Urological · 75d
Cleared Aug 11, 1997
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc.
HIR · Perineometer · 208d
Cleared Jul 29, 1997
VG 200 VIDEO GASTROSCOPE
K971734 · Welch Allyn, Inc.
FDS · Gastroscope And Accessories, Flexible/rigid · 78d
Cleared Jul 24, 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
K971180 · C.R. Bard, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 115d
Cleared Jul 24, 1997
AMS COAGULOOP RESECTION ELECTRODE
K971512 · American Medical Systems, Inc.
FAS · Electrode, Electrosurgical, Active, Urological · 87d
Cleared Jul 18, 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · Sil-Med Corp.
FJS · Catheter, Peritoneal, Long-term Indwelling · 463d
Cleared Jul 16, 1997
OLYMPUS OES OTV-S5C VIDEO SYSTEM
K971416 · Olympus America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 91d
Cleared Jul 14, 1997
MRI NEEDLES
K963565 · Cook, Inc.
FCG · Biopsy Needle · 312d
Cleared Jul 08, 1997
RMI HEMOCONCENTRATOR PREFERENCE PACK
K970739 · Research Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 130d
Cleared Jul 03, 1997
2008H ON LINE CLEARANCE MONITOR
K961465 · Fresenius USA, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 442d
Cleared Jul 01, 1997
OLYMPUS CD-6C-1 COAGULATION ELECTRODE
K971328 · Olympus America, Inc.
FFE · System, Water Jet Catheter, Renal · 82d
Cleared Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 189d
Cleared Jun 30, 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · Empi
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 63d
Cleared Jun 27, 1997
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K963160 · Olympus America, Inc.
PKL · Hemostatic Metal Clip For The Gi Tract · 317d
Cleared Jun 27, 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
K970720 · Ethicon Endo-Surgery, Inc.
OCW · Endoscopic Tissue Approximation Device · 120d
Cleared Jun 27, 1997
STONE EXTRACTOR
K971123 · Phx Technologies Corp.
OCZ · Endoscopic Grasping/cutting Instrument, Non-powered · 92d
Cleared Jun 25, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
K971541 · Hollister, Inc.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 58d
Cleared Jun 20, 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
K964688 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 210d
Cleared Jun 20, 1997
COAXIAL NEEDLE
K971842 · United States Endoscopy Group, Inc.
FCG · Biopsy Needle · 32d
Cleared Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · Omron Healthcare, Inc.
MNW · Analyzer, Body Composition · 280d
Cleared Jun 11, 1997
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc.
BSS · Tube, Nasogastric · 405d
Cleared Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · Medline Industries, Inc.
LJH · System, Irrigation, Urological · 88d
Cleared Jun 02, 1997
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
K970446 · Althin Medical AB an Affiliate of Baxter Intl
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 117d
Cleared May 28, 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · Arthrocare Corp.
FAS · Electrode, Electrosurgical, Active, Urological · 106d

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All categories 5373 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 130 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 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 94 FAD Stent, Ureteral 94 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