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
8421 Gastroenterology & Urology devices
Cleared
May 17, 2004
NEXT GENERATION SALEM SUMP
FEG
Tube, Double Lumen For Intestinal Decompression And/or Intubation
90d
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 14, 2004
STEP-TIP CHRONIC HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
60d
Cleared
May 11, 2004
Y2K2 ENTERNAL FEEDING MANAGER
KNT
Tubes, Gastrointestinal (and Accessories)
459d
Cleared
May 10, 2004
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
19d
Cleared
May 07, 2004
VIADUCT MINISCOPE AND ACCESSORIES
GCT
Light Source, Endoscope, Xenon Arc
25d
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
Cleared
Apr 28, 2004
TRIPTER X-1 COMPACT
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
64d
Cleared
Apr 28, 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
47d
Cleared
Apr 27, 2004
RENACLEAN SH DIALYZER CLEANING SYSTEM
LIF
Dialyzer Reprocessing System
174d
Cleared
Apr 27, 2004
AQUADEX SYSTEM 100, MODEL A1100
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
61d
Cleared
Apr 19, 2004
BICARD MIXING SYSTEM
FIN
Tank, Holding, Dialysis
440d
Cleared
Apr 19, 2004
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
62d
Cleared
Apr 19, 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
MSD
Catheter, Hemodialysis, Implanted
52d
Cleared
Apr 15, 2004
PIGGYBACK IRRIGATING SYSTEM
LJH
System, Irrigation, Urological
90d
Cleared
Apr 15, 2004
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
FAJ
Cystoscope And Accessories, Flexible/rigid
76d
Cleared
Apr 14, 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
16d
Cleared
Apr 08, 2004
CONVATEC FECAL MANAGEMENT SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
217d
Cleared
Apr 08, 2004
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
MNW
Analyzer, Body Composition
191d
Cleared
Apr 08, 2004
ONEVIEW INTERFACE
FKP
System, Dialysate Delivery, Single Patient
85d
Cleared
Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
FGE
Stents, Drains And Dilators For The Biliary Ducts
23d
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