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
8432 Gastroenterology & Urology devices
Cleared
Feb 07, 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
FFX
System, Gastrointestinal Motility (electrical)
22d
Cleared
Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
63d
Cleared
Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
90d
Cleared
Feb 01, 2001
SUCTION IRRIGATOR
FHF
System, Evacuator, Fluid
87d
Cleared
Feb 01, 2001
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
FKP
System, Dialysate Delivery, Single Patient
71d
Cleared
Feb 01, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
FGM
Probe And Director, Gastro-urology
21d
Cleared
Jan 30, 2001
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT
FDS
Gastroscope And Accessories, Flexible/rigid
190d
Cleared
Jan 24, 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jan 23, 2001
HORIZONS ERCP CANNULA
FGE
Stents, Drains And Dilators For The Biliary Ducts
183d
Cleared
Jan 23, 2001
HORIZONS PAPILLOTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
183d
Cleared
Jan 22, 2001
GLUTARTEST 1 REAGENT STRIP
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
203d
Cleared
Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
FAD
Stent, Ureteral
20d
Cleared
Jan 18, 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
KNW
Instrument, Biopsy
90d
Cleared
Jan 17, 2001
LIFEMATE HEMOFILTRATION SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
271d
Cleared
Jan 11, 2001
PENILE CONSTRICTOR RING
LKY
Device, External Penile Rigidity
206d
Cleared
Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jan 05, 2001
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
EZL
Catheter, Retention Type, Balloon
77d
Cleared
Jan 05, 2001
BARD LUMINEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
15d
Cleared
Jan 04, 2001
FRESENIUS OPTIFLUX 200A
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
52d
Cleared
Jan 04, 2001
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Jan 02, 2001
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
KPM
Shunt, Peritoneal
56d
Cleared
Jan 02, 2001
WATER PURIFICATION SYSTEM
FIP
Subsystem, Water Purification
378d
Cleared
Dec 28, 2000
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Dec 27, 2000
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
110d
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