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
8412 Gastroenterology & Urology devices
Cleared
Jan 09, 2009
DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
KNT
Tubes, Gastrointestinal (and Accessories)
102d
Cleared
Dec 29, 2008
CORFLO ANTI IV ENTERAL FEEDING TUBE
FPD
Tube, Feeding
59d
Cleared
Dec 29, 2008
FRESENIUS STERILE STAY SAFE CAP
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
31d
Cleared
Dec 23, 2008
TORNADO ROTATABEL SNARE AND POLYP CATCHER
FDI
Snare, Flexible
70d
Cleared
Dec 19, 2008
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
144d
Cleared
Dec 19, 2008
PRISMAFLO II
KOC
Accessories, Blood Circuit, Hemodialysis
91d
Cleared
Dec 19, 2008
STRYKER LED LIGHTSOURCE
FCW
Light Source, Fiberoptic, Routine
86d
Cleared
Dec 18, 2008
URONIRS, MODEL 2000
FEN
Device, Cystometric, Hydraulic
93d
Cleared
Dec 18, 2008
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
GCT
Light Source, Endoscope, Xenon Arc
78d
Cleared
Dec 12, 2008
FROG
FPD
Tube, Feeding
436d
Cleared
Dec 05, 2008
LUBRICANO STERILE GEL
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
144d
Cleared
Dec 03, 2008
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
KNT
Tubes, Gastrointestinal (and Accessories)
167d
Cleared
Nov 26, 2008
OMNI-DL SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
264d
Cleared
Nov 25, 2008
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
MNW
Analyzer, Body Composition
109d
Cleared
Nov 25, 2008
ENTERAL ONLY EXTENSION SET
KNT
Tubes, Gastrointestinal (and Accessories)
74d
Cleared
Nov 19, 2008
NITI-S BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
329d
Cleared
Nov 19, 2008
SH14 HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
194d
Cleared
Nov 13, 2008
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
FFL
Dislodger, Stone, Basket, Ureteral, Metal
50d
Cleared
Nov 07, 2008
ENTERAL PUMP SET, MODEL 20-1010
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Nov 07, 2008
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
FFX
System, Gastrointestinal Motility (electrical)
109d
Cleared
Nov 06, 2008
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
OCT
Anti Fog Solution And Accessories, Endoscopy
247d
Cleared
Nov 06, 2008
OLYMPUS CHF TYPE V
FBN
Choledochoscope And Accessories, Flexible/rigid
167d
Cleared
Oct 30, 2008
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
KNT
Tubes, Gastrointestinal (and Accessories)
84d
Cleared
Oct 28, 2008
OPTIFLUX F250NR, MODEL 0500325E
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
68d
Cleared
Oct 27, 2008
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
FGE
Stents, Drains And Dilators For The Biliary Ducts
130d
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