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
8427 Gastroenterology & Urology devices
Cleared
Feb 06, 2003
BIOARC SP SLING KIT
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
23d
Cleared
Jan 30, 2003
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
MPB
Catheter, Hemodialysis, Non-implanted
205d
Cleared
Jan 29, 2003
1-CCD ENDOCAM 5520 SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
90d
Cleared
Jan 27, 2003
SPEEDICATH
GBM
Catheter, Urethral
119d
Cleared
Jan 23, 2003
BARD ER URETERAL STENT WITH SUTURE
FAD
Stent, Ureteral
181d
Cleared
Jan 21, 2003
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
FGE
Stents, Drains And Dilators For The Biliary Ducts
683d
Cleared
Jan 17, 2003
TRIPTER X-1 COMPACT DUET
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
88d
Cleared
Jan 15, 2003
MODIFICATION TO TEMNO BIOPSY NEEDLES
FCG
Biopsy Needle
30d
Cleared
Jan 14, 2003
ENDOSCOPIC LIGHT SOURCE XL180/L3
GCT
Light Source, Endoscope, Xenon Arc
90d
Cleared
Jan 14, 2003
ULTROID HEMORRHOID MANAGEMENT SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
71d
Cleared
Jan 07, 2003
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
201d
Cleared
Jan 06, 2003
CUSTODIOL HTK SOLUTION
KDL
Set, Perfusion, Kidney, Disposable
291d
Cleared
Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jan 03, 2003
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
157d
Cleared
Jan 03, 2003
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
FGB
Ureteroscope And Accessories, Flexible/rigid
88d
Cleared
Jan 02, 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
198d
Cleared
Dec 31, 2002
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
FFS
Image, Illumination, Fiberoptic, For Endoscope
63d
Cleared
Dec 26, 2002
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
FDF
Colonoscope And Accessories, Flexible/rigid
87d
Cleared
Dec 26, 2002
KEGELMASTER 2000
HIR
Perineometer
84d
Cleared
Dec 23, 2002
LTFS230
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
208d
Cleared
Dec 23, 2002
AIM-V (R) MEDIUM, MODEL 087-0112
NDS
Media, Culture, Ex Vivo, Tissue And Cell
179d
Cleared
Dec 23, 2002
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
147d
Cleared
Dec 23, 2002
DISPOSABLE ASPIRATION NEEDLE NA-200H
FCG
Biopsy Needle
83d
Cleared
Dec 20, 2002
MODIFICATION TO NANMA VACUUM PUMP
LKY
Device, External Penile Rigidity
458d
Cleared
Dec 20, 2002
GYNEFLEX
HIR
Perineometer
256d
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