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
5369 Gastroenterology & Urology devices
Cleared
May 24, 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
155d
Cleared
May 24, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
NSI
System, Imaging, Esophageal, Wireless, Capsule
61d
Cleared
May 23, 2006
REPROCESSED ENDOSCOPIC TROCAR
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
272d
Cleared
May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
MQR
Stent, Colonic, Metallic, Expandable
92d
Cleared
May 08, 2006
GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
129d
Cleared
Apr 28, 2006
ENTAKE STANDARD AND SAFETY PEG SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
15d
Cleared
Apr 27, 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Mar 31, 2006
NXSTAGE DIALYSATE PREPARATION MODULE
FKR
Subsystem, Proportioning
53d
Cleared
Mar 29, 2006
PEDIATRIC URETERAL STENT
FAD
Stent, Ureteral
15d
Cleared
Mar 23, 2006
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Mar 16, 2006
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
FAJ
Cystoscope And Accessories, Flexible/rigid
85d
Cleared
Mar 09, 2006
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
64d
Cleared
Mar 08, 2006
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
58d
Cleared
Feb 28, 2006
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
OCY
Endoscopic Guidewire, Gastroenterology-urology
54d
Cleared
Feb 16, 2006
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
EZL
Catheter, Retention Type, Balloon
191d
Cleared
Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
FKX
System, Peritoneal, Automatic Delivery
62d
Cleared
Feb 03, 2006
AMS MALE TRANSOBTURATOR SLING SYSTEM
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
60d
Cleared
Jan 31, 2006
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
291d
Cleared
Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
62d
Cleared
Dec 22, 2005
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
27d
Cleared
Dec 21, 2005
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
14d
Cleared
Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
85d
Cleared
Dec 01, 2005
GIVEN DIAGNOSTIC SYSTEM
NSI
System, Imaging, Esophageal, Wireless, Capsule
112d
Cleared
Nov 30, 2005
MEDCOMP SPLIT CATH II
MSD
Catheter, Hemodialysis, Implanted
197d
Cleared
Nov 28, 2005
GYNECARE TVT SECUR SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
88d
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