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
Jun 20, 2012
GYRUS AMCI PK BUTTON ELECTRODE
FAS
Electrode, Electrosurgical, Active, Urological
114d
Cleared
Jun 20, 2012
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
FAS
Electrode, Electrosurgical, Active, Urological
131d
Cleared
Jun 12, 2012
MODULTH SLK
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
90d
Cleared
Jun 11, 2012
REPROCESSED ENDOSCOPIC TROCARS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
48d
Cleared
Jun 08, 2012
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
KNT
Tubes, Gastrointestinal (and Accessories)
252d
Cleared
May 30, 2012
ENDOSCOPIC RETRIEVAL DEVICE
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
140d
Cleared
May 18, 2012
CONCENTRIC BALLOON GOOGLE
ODC
Endoscope Channel Accessory
245d
Cleared
May 17, 2012
EVOLUTION COLONIC STENT SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
171d
Cleared
May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
30d
Cleared
Apr 20, 2012
SAFETY SCREW CONNECTOR
KNT
Tubes, Gastrointestinal (and Accessories)
123d
Cleared
Apr 06, 2012
IMAGE1 GI CCU MODEL 22203020-114
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
268d
Cleared
Apr 04, 2012
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
MPB
Catheter, Hemodialysis, Non-implanted
30d
Cleared
Mar 28, 2012
AQUASHIELD CO2 SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
71d
Cleared
Mar 20, 2012
V1 SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
272d
Cleared
Mar 19, 2012
PLEURX PERITONEAL CATHETER SYSTEM
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
81d
Cleared
Mar 09, 2012
HEMO-CATH 10F, HEMO-CATH 12.5F
MSD
Catheter, Hemodialysis, Implanted
107d
Cleared
Feb 16, 2012
EVIS EXERA III VIDEO SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
155d
Cleared
Feb 14, 2012
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
67d
Cleared
Feb 14, 2012
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
81d
Cleared
Feb 10, 2012
CRE DITATATION BALLON
FGE
Stents, Drains And Dilators For The Biliary Ducts
126d
Cleared
Feb 02, 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Jan 25, 2012
ENDOCHOICE WATER BOTTLE CAP SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
141d
Cleared
Jan 06, 2012
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
ODA
Endoscopic Central Control Unit
255d
Cleared
Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
119d
Cleared
Dec 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
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