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
May 14, 2015
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
FDS
Gastroscope And Accessories, Flexible/rigid
240d
Cleared
May 11, 2015
Magic3 Go Intermittent Urinary Catheter
EZD
Catheter, Straight
89d
Cleared
Apr 27, 2015
Medline Enteral Feeding Sets
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
81d
Cleared
Apr 02, 2015
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
164d
Cleared
Mar 20, 2015
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
121d
Cleared
Mar 19, 2015
Imbibe Aspirating XIA Taps
KNW
Instrument, Biopsy
94d
Cleared
Mar 10, 2015
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON
OCX
Endoscopic Irrigation/suction System
223d
Cleared
Feb 27, 2015
Single Use Biliary Balloon Dilator
FGE
Stents, Drains And Dilators For The Biliary Ducts
101d
Cleared
Feb 25, 2015
GastriSail Gastric Positioning System
KNT
Tubes, Gastrointestinal (and Accessories)
120d
Cleared
Feb 23, 2015
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
PNR
Enteral Syringes With Enteral Specific Connectors
203d
Cleared
Feb 08, 2015
ENDOCAPSULE SOFTWARE 10
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
142d
Cleared
Jan 20, 2015
Speedicath Compact Male
GBM
Catheter, Urethral
76d
Cleared
Jan 20, 2015
ENDOCHOICE WATER BOTTLE CAP SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
167d
Cleared
Jan 16, 2015
SpyGlass DS Direct Visualization System
FBN
Choledochoscope And Accessories, Flexible/rigid
100d
Cleared
Jan 09, 2015
Medline Silicone Foley Catheter
EZL
Catheter, Retention Type, Balloon
114d
Cleared
Dec 19, 2014
Echotip Procore HD Ultrasound Biopsy Needle
FCG
Biopsy Needle
88d
Cleared
Dec 19, 2014
NXSTAGE SYSTEM ONE
ODN
Ultrafiltration-controlled Nocturnal Dialysate Delivery System
172d
Cleared
Dec 18, 2014
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
OCX
Endoscopic Irrigation/suction System
43d
Cleared
Dec 17, 2014
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
316d
Cleared
Dec 01, 2014
Resolution Clip
PKL
Hemostatic Metal Clip For The Gi Tract
48d
Cleared
Nov 26, 2014
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
182d
Cleared
Nov 18, 2014
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
FEW
Catheter, Malecot
309d
Cleared
Nov 05, 2014
Acrobat Calibrated Tip Wire Guide
OCY
Endoscopic Guidewire, Gastroenterology-urology
26d
Cleared
Oct 31, 2014
Bard RiteCath Intermittent Urinary Catheter
EZD
Catheter, Straight
49d
Cleared
Oct 23, 2014
Flexible Video-Uretero-Choledochoscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
42d
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