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
May 09, 2001
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
33d
Cleared
May 04, 2001
MPS M ELECTRODE
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
238d
Cleared
May 04, 2001
RENAX A.V. FISTULA NEEDLE SETS
FIE
Needle, Fistula
211d
Cleared
May 04, 2001
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
LQC
Lithotriptor, Biliary Mechanical
17d
Cleared
May 03, 2001
SANARUS CORE TISSUE BIOPSY SYSTEM
KNW
Instrument, Biopsy
168d
Cleared
Apr 30, 2001
COBE HC 700 MIDI HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
214d
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
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
185d
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 10, 2001
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
FHO
Pneumoperitoneum Needle
26d
Cleared
Apr 09, 2001
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
MSD
Catheter, Hemodialysis, Implanted
203d
Cleared
Apr 05, 2001
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
HIR
Perineometer
225d
Cleared
Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
FKX
System, Peritoneal, Automatic Delivery
202d
Cleared
Apr 05, 2001
STS-T LITHOTRIPTER, MODEL STS-T
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
10d
Cleared
Apr 02, 2001
FLEXIBLE ENDOSCOPIC SCISSORS
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
49d
Cleared
Mar 29, 2001
MENTOR SELF-CATH CLOSED SYSTEM
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
104d
Cleared
Mar 29, 2001
REDTECH GIPC 2000
FFX
System, Gastrointestinal Motility (electrical)
90d
Cleared
Mar 28, 2001
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
MSD
Catheter, Hemodialysis, Implanted
191d
Cleared
Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
MSD
Catheter, Hemodialysis, Implanted
30d
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