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
2951–2975 of 5373
Cleared Jul 31, 1996
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
K961706 · Fresenius USA, Inc.
LKN · Separator, Automated, Blood Cell And Plasma, Therapeutic · 90d
Cleared Jul 31, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
K962387 · Olympus America, Inc.
FFL · Dislodger, Stone, Basket, Ureteral, Metal · 41d
Cleared Jul 30, 1996
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · C.R. Bard, Inc.
KNW · Instrument, Biopsy · 63d
Cleared Jul 24, 1996
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
K960176 · C.R. Bard, Inc.
FEG · Tube, Double Lumen For Intestinal Decompression And/or Intubation · 190d
Cleared Jul 24, 1996
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc.
FAD · Stent, Ureteral · 106d
Cleared Jul 22, 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762 · United States Endoscopy Group, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 76d
Cleared Jul 18, 1996
OLYMPUS BASKET GRASPERS (UROLOGY)
K961611 · Olympus America, Inc.
OCZ · Endoscopic Grasping/cutting Instrument, Non-powered · 84d
Cleared Jul 18, 1996
CIRCLE NEPHROSTOMY CATHETER SET
K961933 · Cook Urological, Inc.
LJE · Catheter, Nephrostomy · 62d
Cleared Jul 18, 1996
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
K962604 · Convatec, A Division of E.R. Squibb & Sons
FAQ · Bag, Urine Collection, Leg, For External Use, Sterile · 16d
Cleared Jul 15, 1996
NEEDLE CATHETER
K961846 · Boston Scientific Corp
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 63d
Cleared Jul 10, 1996
WALLSTENT ENTERAL ENDOPROTHESIS
K954290 · Boston Scientific Scimed, Inc.
MQR · Stent, Colonic, Metallic, Expandable · 300d
Cleared Jul 09, 1996
EG-2940, VIDEO GASTROSCOPE
K961564 · Pentax Precision Instrument Corp.
FDS · Gastroscope And Accessories, Flexible/rigid · 77d
Cleared Jul 09, 1996
ED-344OT
K961568 · Pentax Precision Instrument Corp.
FDT · Duodenoscope And Accessories, Flexible/rigid · 77d
Cleared Jul 03, 1996
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460 · Fresenius USA, Inc.
MQS · System, Hemodialysis, Access Recirculation Monitoring · 831d
Cleared Jun 27, 1996
LIBERTY LITE PFS SYSTEM
K960496 · Utah Medical Products, Inc.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 147d
Cleared Jun 25, 1996
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
K961390 · Ethicon Endo-Surgery, Inc.
OCW · Endoscopic Tissue Approximation Device · 76d
Cleared Jun 24, 1996
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · Pentax Precision Instrument Corp.
FAM · Sigmoidoscope And Accessories, Flexible/rigid · 62d
Cleared Jun 24, 1996
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
K961570 · Pentax Precision Instrument Corp.
FDF · Colonoscope And Accessories, Flexible/rigid · 62d
Cleared Jun 19, 1996
EC-384OTL, VIDEO COLONSCOPE
K961563 · Pentax Precision Instrument Corp.
FDF · Colonoscope And Accessories, Flexible/rigid · 57d
Cleared Jun 13, 1996
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423 · Fresenius USA, Inc.
FKP · System, Dialysate Delivery, Single Patient · 198d
Cleared Jun 11, 1996
AQ HYDROPHILIC UROLOGICAL CATHETERS
K962004 · Cook Urological, Inc.
EYB · Catheter, Ureteral, Gastro-urology · 20d
Cleared Jun 10, 1996
LESE STENTS SETS
K952513 · Cook Urological, Inc.
FAD · Stent, Ureteral · 377d
Cleared Jun 05, 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181 · United States Endoscopy Group, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 205d
Cleared Jun 04, 1996
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
K953681 · Haemonetics Corp.
LKN · Separator, Automated, Blood Cell And Plasma, Therapeutic · 302d
Cleared May 28, 1996
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K961069 · Arthrocare Corp.
FAS · Electrode, Electrosurgical, Active, Urological · 71d

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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