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
Aug 27, 2004
NXSTAGE PUREFLOW-B SOLUTION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
28d
Cleared
Aug 26, 2004
STORZ MODULITH, MODEL SLX-F2
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
184d
Cleared
Aug 23, 2004
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
7d
Cleared
Aug 19, 2004
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
FJL
Resectoscope
65d
Cleared
Aug 11, 2004
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
22d
Cleared
Aug 09, 2004
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
314d
Cleared
Jul 29, 2004
15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
MSD
Catheter, Hemodialysis, Implanted
104d
Cleared
Jul 21, 2004
VIABIL BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
54d
Cleared
Jul 08, 2004
INJECTOR NEEDLE/SNARE
FDI
Snare, Flexible
86d
Cleared
Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
FGE
Stents, Drains And Dilators For The Biliary Ducts
22d
Cleared
Jul 02, 2004
ZILVER BILIARY STENT SYSTEM USW
FGE
Stents, Drains And Dilators For The Biliary Ducts
84d
Cleared
Jul 02, 2004
NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
35d
Cleared
Jun 25, 2004
WILOSN-COOK BILIARY DILATION BALLOON
FGE
Stents, Drains And Dilators For The Biliary Ducts
88d
Cleared
Jun 23, 2004
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
118d
Cleared
Jun 10, 2004
DISPOSABLE OVERTUBE
FED
Endoscopic Access Overtube, Gastroenterology-urology
71d
Cleared
Jun 07, 2004
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
FDA
Enteroscope And Accessories
147d
Cleared
May 26, 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
70d
Cleared
May 20, 2004
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
FDX
Endoscopic Cytology Brush
100d
Cleared
May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
57d
Cleared
May 17, 2004
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
12d
Cleared
May 14, 2004
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
EZL
Catheter, Retention Type, Balloon
77d
Cleared
May 07, 2004
USW NEEDLEKNIFE PAPILLOTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
22d
Cleared
May 06, 2004
EASY CORE BIOPSY SYSTEM
FCG
Biopsy Needle
30d
Cleared
Apr 30, 2004
SENORX BIOPSY DEVICE II
KNW
Instrument, Biopsy
29d
Cleared
Apr 28, 2004
ENDOMAT LC PUMP, MODEL 20 3303 20
OCX
Endoscopic Irrigation/suction System
356d
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