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
8425 Gastroenterology & Urology devices
Cleared
May 02, 2003
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
88d
Cleared
May 02, 2003
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
MNW
Analyzer, Body Composition
88d
Cleared
Apr 30, 2003
HEMO-STREAM HEMODIALYSIS CATHETER SET
MSD
Catheter, Hemodialysis, Implanted
162d
Cleared
Apr 30, 2003
ATHENA PELVIC MUSCLE TRAINER
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
159d
Cleared
Apr 30, 2003
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
78d
Cleared
Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
28d
Cleared
Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
28d
Cleared
Apr 25, 2003
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY
MSD
Catheter, Hemodialysis, Implanted
28d
Cleared
Apr 22, 2003
VITALCARE URETHRAL CATHETER
GBM
Catheter, Urethral
314d
Cleared
Apr 22, 2003
VITALCARE FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
314d
Cleared
Apr 21, 2003
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
MNW
Analyzer, Body Composition
90d
Cleared
Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
Apr 16, 2003
PANCREATIC DRAINAGE TUBE
FGE
Stents, Drains And Dilators For The Biliary Ducts
330d
Cleared
Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
29d
Cleared
Apr 14, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
193d
Cleared
Apr 10, 2003
VITALCARE URETHRAL CATHETER RED RUBBER
EZD
Catheter, Straight
141d
Cleared
Apr 07, 2003
PORTABLE RO+ MODEL MROS09
FIP
Subsystem, Water Purification
90d
Cleared
Apr 03, 2003
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
KNT
Tubes, Gastrointestinal (and Accessories)
279d
Cleared
Mar 31, 2003
JOSTENT SELFX, MODELS 015SX4406
FGE
Stents, Drains And Dilators For The Biliary Ducts
98d
Cleared
Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
25d
Cleared
Mar 24, 2003
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
ODC
Endoscope Channel Accessory
90d
Cleared
Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
62d
Cleared
Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
FGE
Stents, Drains And Dilators For The Biliary Ducts
67d
Cleared
Mar 20, 2003
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
FIE
Needle, Fistula
178d
Cleared
Mar 19, 2003
OPTION-VF URINARY CATHETER, FV14218
EZL
Catheter, Retention Type, Balloon
183d
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