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
8435 Gastroenterology & Urology devices
Cleared
Oct 21, 1999
MEDTRONIC AVE BRIDGE STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
31d
Cleared
Oct 20, 1999
50 W METAL HALIDE ILLUMINATOR, VES 0501.
FCW
Light Source, Fiberoptic, Routine
90d
Cleared
Oct 20, 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
Oct 15, 1999
KSEA SCBCOM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
81d
Cleared
Oct 15, 1999
MODIFICATION TO INTRASTENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
56d
Cleared
Oct 13, 1999
NEO-2 METER
FIZ
Meter, Conductivity, Non-remote
84d
Cleared
Oct 13, 1999
URETERO-RENOSCOPE
FGB
Ureteroscope And Accessories, Flexible/rigid
77d
Cleared
Oct 08, 1999
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
88d
Cleared
Oct 07, 1999
BAHO AUTOCLAVABLE CYSTOSCOPE
FAJ
Cystoscope And Accessories, Flexible/rigid
34d
Cleared
Oct 06, 1999
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
23d
Cleared
Oct 05, 1999
V.T.S., INC. (V.T.-3)
LKY
Device, External Penile Rigidity
75d
Cleared
Sep 29, 1999
OLYMPUS WORKING ELEMENT FOR PROBES
FDC
Resectoscope, Working Element
97d
Cleared
Sep 28, 1999
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
EZL
Catheter, Retention Type, Balloon
223d
Cleared
Sep 24, 1999
A-15 HEMODIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
52d
Cleared
Sep 23, 1999
A-18 HEMODIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
52d
Cleared
Sep 17, 1999
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
FDS
Gastroscope And Accessories, Flexible/rigid
284d
Cleared
Sep 15, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Sep 14, 1999
LUMENON XENON LIGHT SOURCE
GCT
Light Source, Endoscope, Xenon Arc
89d
Cleared
Sep 14, 1999
XENON LIGHT SOURCE PES 1
GCT
Light Source, Endoscope, Xenon Arc
47d
Cleared
Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Sep 10, 1999
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
FLD
Apparatus, Hemoperfusion, Sorbent
72d
Cleared
Sep 03, 1999
FRESENIUS BLOOD VOLUME MONITOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
379d
Cleared
Sep 03, 1999
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
LJE
Catheter, Nephrostomy
184d
Cleared
Sep 03, 1999
UROLOGICAL CATHETER
GBM
Catheter, Urethral
71d
Cleared
Sep 02, 1999
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
FGE
Stents, Drains And Dilators For The Biliary Ducts
170d
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