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
8388 Gastroenterology & Urology devices
Cleared
Apr 14, 2014
ELISIO-H HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
77d
Cleared
Apr 10, 2014
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
FDS
Gastroscope And Accessories, Flexible/rigid
289d
Cleared
Apr 09, 2014
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
KNT
Tubes, Gastrointestinal (and Accessories)
506d
Cleared
Apr 09, 2014
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
FDF
Colonoscope And Accessories, Flexible/rigid
292d
Cleared
Apr 08, 2014
MANDREL GUIDEWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
41d
Cleared
Apr 04, 2014
BARD RITECATH INTERMITTENT CATHETER
EZD
Catheter, Straight
143d
Cleared
Apr 04, 2014
US ENDOSCOPY DISTAL ATTACHMENT CAP
OCX
Endoscopic Irrigation/suction System
53d
Cleared
Apr 03, 2014
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
339d
Cleared
Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
100d
Cleared
Mar 26, 2014
CORGRIP
KNT
Tubes, Gastrointestinal (and Accessories)
121d
Cleared
Mar 26, 2014
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
FLD
Apparatus, Hemoperfusion, Sorbent
100d
Cleared
Mar 25, 2014
SAFETY BIOPSY NEEDLE SYSTEM
FCG
Biopsy Needle
62d
Cleared
Mar 19, 2014
SRS ENDOSCOPIC STAPLING SYSTEM
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
251d
Cleared
Mar 19, 2014
SEAL SINGLE-USE BIOPSY VALVE
OCX
Endoscopic Irrigation/suction System
100d
Cleared
Mar 12, 2014
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
337d
Cleared
Mar 12, 2014
TORRENT IRRIGATION SYSTEM
OCX
Endoscopic Irrigation/suction System
22d
Cleared
Mar 07, 2014
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
PGU
Spatial Imaging For Display Of Endoscope Position
67d
Cleared
Mar 07, 2014
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
FED
Endoscopic Access Overtube, Gastroenterology-urology
25d
Cleared
Mar 04, 2014
LIGHTHOUSE URINARY CATHETER
EZL
Catheter, Retention Type, Balloon
47d
Cleared
Mar 03, 2014
NXSTAGE SYSTEM ONE WITH NXVIEW
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
104d
Cleared
Feb 28, 2014
PRESTO BREAST BIOPSY DEVICE
KNW
Instrument, Biopsy
87d
Cleared
Feb 26, 2014
ANAL RECTAL OVERTUBE
FED
Endoscopic Access Overtube, Gastroenterology-urology
268d
Cleared
Feb 25, 2014
E-Z CHECK OZONE TEST STRIPS
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
211d
Cleared
Feb 25, 2014
INTONEMV
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
57d
Cleared
Feb 24, 2014
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
EZD
Catheter, Straight
91d
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