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
5367 Gastroenterology & Urology devices
Cleared
Apr 29, 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
174d
Cleared
Apr 23, 2013
NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
285d
Cleared
Apr 17, 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
KNT
Tubes, Gastrointestinal (and Accessories)
128d
Cleared
Apr 11, 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
238d
Cleared
Apr 04, 2013
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
254d
Cleared
Apr 03, 2013
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
42d
Cleared
Mar 07, 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
122d
Cleared
Mar 06, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
FPD
Tube, Feeding
352d
Cleared
Mar 01, 2013
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
FED
Endoscopic Access Overtube, Gastroenterology-urology
91d
Cleared
Mar 01, 2013
EVOLUTION BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
291d
Cleared
Feb 04, 2013
AUTOMATED ENDOSCOPE LEAK TESTER
PCV
Endoscopic Leak Tester
63d
Cleared
Jan 31, 2013
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
MSD
Catheter, Hemodialysis, Implanted
112d
Cleared
Jan 25, 2013
POWER LED 175
FCW
Light Source, Fiberoptic, Routine
35d
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
Dec 21, 2012
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
437d
Cleared
Dec 18, 2012
NUTRISAFE 2 FEEDING TUBE
FPD
Tube, Feeding
250d
Cleared
Dec 14, 2012
VIDEO SYSTEM CENTER
NTN
Led Light Source
88d
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 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 09, 2012
CRIT-LINE CLIP (CLIC)
KOC
Accessories, Blood Circuit, Hemodialysis
161d
Cleared
Nov 05, 2012
ALTIS SINGLE INCISION CLING SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
160d
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