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
8390 Gastroenterology & Urology devices
Cleared
Jan 17, 2013
FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
ONW
Hemodialysis System For Home Use
248d
Cleared
Jan 16, 2013
SWISS LITHOBREAKER
FFK
Lithotriptor, Electro-hydraulic
110d
Cleared
Jan 10, 2013
EC SINGLE USE, POLYPECTOMY SNARE
FDI
Snare, Flexible
87d
Cleared
Jan 10, 2013
XENX STONE MANAGEMENT DEVICE
OCY
Endoscopic Guidewire, Gastroenterology-urology
63d
Cleared
Jan 09, 2013
TRANSTEK GLASS BODY FAT ANALYZER
MNW
Analyzer, Body Composition
30d
Cleared
Jan 04, 2013
BODY FAT SCALE MODEL SF-371
MNW
Analyzer, Body Composition
100d
Cleared
Jan 03, 2013
NEO ERCP GUIDEWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
56d
Cleared
Dec 21, 2012
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
437d
Cleared
Dec 20, 2012
INVENDO C25 COLONOSCOPY SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
204d
Cleared
Dec 20, 2012
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
KNT
Tubes, Gastrointestinal (and Accessories)
22d
Cleared
Dec 19, 2012
OVS1 VIDEO SYSTEM
FCW
Light Source, Fiberoptic, Routine
49d
Cleared
Dec 18, 2012
NUTRISAFE 2 FEEDING TUBE
FPD
Tube, Feeding
250d
Cleared
Dec 14, 2012
MOLECULAR ADSORBENT RECIRCULATING(MARS)
FLD
Apparatus, Hemoperfusion, Sorbent
401d
Cleared
Dec 14, 2012
VIDEO SYSTEM CENTER
NTN
Led Light Source
88d
Cleared
Dec 14, 2012
GYRUS ACMI BICOAG HEMOSTASIS PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
49d
Cleared
Dec 13, 2012
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
FAP
Cystometric Gas (carbon-dioxide) On Hydraulic Device
357d
Cleared
Dec 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
FED
Endoscopic Access Overtube, Gastroenterology-urology
104d
Cleared
Dec 11, 2012
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
FDS
Gastroscope And Accessories, Flexible/rigid
47d
Cleared
Dec 10, 2012
JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN
OCX
Endoscopic Irrigation/suction System
95d
Cleared
Dec 07, 2012
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
108d
Cleared
Dec 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
217d
Cleared
Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
PKL
Hemostatic Metal Clip For The Gi Tract
94d
Cleared
Nov 27, 2012
WATER BOTTLE CAP IRRIGATON SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
250d
Cleared
Nov 15, 2012
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
KNW
Instrument, Biopsy
28d
Cleared
Nov 09, 2012
CRIT-LINE CLIP (CLIC)
KOC
Accessories, Blood Circuit, Hemodialysis
161d
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