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
8419 Gastroenterology & Urology devices
Cleared
Jan 05, 2007
FUSION QUATTRO EXTRACTION BALLOON XL
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
25d
Cleared
Jan 04, 2007
GAMBRO POSICLEAR
FIP
Subsystem, Water Purification
192d
Cleared
Dec 28, 2006
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
MNW
Analyzer, Body Composition
112d
Cleared
Dec 27, 2006
RIGIDOMETER, MODEL DIR-4U
LIL
Monitor, Penile Tumescence
196d
Cleared
Dec 22, 2006
LITHODIAMOND ULTRA
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
221d
Cleared
Dec 22, 2006
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
KGE
Forceps, Biopsy, Electric
116d
Cleared
Dec 19, 2006
NEEDLELESS SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
64d
Cleared
Dec 15, 2006
NEXUS IRRIGATION TUBING SET
LJH
System, Irrigation, Urological
107d
Cleared
Dec 15, 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
30d
Cleared
Dec 13, 2006
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
76d
Cleared
Dec 12, 2006
CYSTOGLIDE INTRODUCER SHEATH
KNY
Accessories, Catheter, G-u
476d
Cleared
Dec 08, 2006
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
FGB
Ureteroscope And Accessories, Flexible/rigid
88d
Cleared
Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
NFK
Kit, Repair, Catheter, Hemodialysis
106d
Cleared
Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
MUM
Stent, Metallic, Expandable, Duodenal
81d
Cleared
Dec 01, 2006
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
KNQ
Dilator, Esophageal
144d
Cleared
Nov 30, 2006
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
70d
Cleared
Nov 17, 2006
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
93d
Cleared
Nov 09, 2006
KARL STORZ VIDEO GASTROSCOPES
FDS
Gastroscope And Accessories, Flexible/rigid
220d
Cleared
Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
MNW
Analyzer, Body Composition
111d
Cleared
Nov 07, 2006
I-STOP TRANS OBTURATOR MALE SLING
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
28d
Cleared
Nov 03, 2006
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
MSD
Catheter, Hemodialysis, Implanted
56d
Cleared
Nov 02, 2006
LITHOGOLD
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
104d
Cleared
Nov 02, 2006
MALE REMEEX SYSTEM
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
84d
Cleared
Oct 27, 2006
SUPERCATH V
FIE
Needle, Fistula
434d
Cleared
Oct 20, 2006
INTEGRA SL
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
85d
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