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
5372 Gastroenterology & Urology devices
Cleared
Jul 17, 2001
MESH URETERAL STENT
FAD
Stent, Ureteral
83d
Cleared
Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
KOD
Catheter, Urological
18d
Cleared
Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
79d
Cleared
Jun 21, 2001
MEDCOMP ASH SPLIT
NFK
Kit, Repair, Catheter, Hemodialysis
30d
Cleared
Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
FJI
Dialyzer, Capillary, Hollow Fiber
58d
Cleared
Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
MSD
Catheter, Hemodialysis, Implanted
242d
Cleared
May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FFK
Lithotriptor, Electro-hydraulic
30d
Cleared
May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
33d
Cleared
May 04, 2001
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
LQC
Lithotriptor, Biliary Mechanical
17d
Cleared
Apr 30, 2001
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
MNG
External Urethral Occluder, Urinary Incontinence-control, Female
82d
Cleared
Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
27d
Cleared
Apr 27, 2001
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FIB
Protector, Transducer, Dialysis
88d
Cleared
Apr 27, 2001
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
KOC
Accessories, Blood Circuit, Hemodialysis
88d
Cleared
Apr 17, 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
209d
Cleared
Apr 13, 2001
NIAGARA SLIM-CATH
MPB
Catheter, Hemodialysis, Non-implanted
29d
Cleared
Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
35d
Cleared
Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
FKX
System, Peritoneal, Automatic Delivery
202d
Cleared
Mar 29, 2001
MENTOR SELF-CATH CLOSED SYSTEM
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
104d
Cleared
Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
MSD
Catheter, Hemodialysis, Implanted
30d
Cleared
Mar 27, 2001
KSEA SCB-RUI SCO
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
174d
Cleared
Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
29d
Cleared
Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
ODC
Endoscope Channel Accessory
26d
Cleared
Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
92d
Cleared
Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
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