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
5373 Gastroenterology & Urology devices
Cleared
Dec 28, 1999
URETERAL ACCESS SHEATH SET - NEW MODELS
FED
Endoscopic Access Overtube, Gastroenterology-urology
60d
Cleared
Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
Cleared
Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
KNT
Tubes, Gastrointestinal (and Accessories)
75d
Cleared
Dec 10, 1999
ENDOSCOPES,10MM DIAMETER 0 DEGREES
GCM
Endoscope, Rigid
85d
Cleared
Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
58d
Cleared
Dec 09, 1999
RUSCH BRILLANT SILICONE FOLEY
EZL
Catheter, Retention Type, Balloon
87d
Cleared
Dec 07, 1999
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
382d
Cleared
Dec 07, 1999
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
284d
Cleared
Nov 28, 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Nov 26, 1999
PBN DILATORS
FGE
Stents, Drains And Dilators For The Biliary Ducts
260d
Cleared
Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
89d
Cleared
Nov 18, 1999
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
KNW
Instrument, Biopsy
90d
Cleared
Nov 17, 1999
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
FGE
Stents, Drains And Dilators For The Biliary Ducts
26d
Cleared
Nov 10, 1999
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
MPB
Catheter, Hemodialysis, Non-implanted
205d
Cleared
Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
FCG
Biopsy Needle
170d
Cleared
Oct 29, 1999
NUTRISAFE EXTENSION TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
144d
Cleared
Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
FGE
Stents, Drains And Dilators For The Biliary Ducts
43d
Cleared
Oct 15, 1999
KSEA SCBCOM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
81d
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
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 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 14, 1999
LUMENON XENON LIGHT SOURCE
GCT
Light Source, Endoscope, Xenon Arc
89d
Cleared
Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Sep 03, 1999
FRESENIUS BLOOD VOLUME MONITOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
379d
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