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
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
Dec 06, 1999
MANUAL BONE MARROW BIOPSY DEVICE
KNW
Instrument, Biopsy
55d
Cleared
Dec 06, 1999
OMNISONIC ENDOSCOPIC DEFLECTOR
GCM
Endoscope, Rigid
55d
Cleared
Nov 30, 1999
CKHEMO, MODEL CKHEMO VERSION 1.0
FKP
System, Dialysate Delivery, Single Patient
147d
Cleared
Nov 29, 1999
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
26d
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 22, 1999
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
FEO
Lithotriptor, Ultrasonic
73d
Cleared
Nov 18, 1999
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
FIP
Subsystem, Water Purification
429d
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 16, 1999
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
FIN
Tank, Holding, Dialysis
89d
Cleared
Nov 10, 1999
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
MPB
Catheter, Hemodialysis, Non-implanted
205d
Cleared
Nov 10, 1999
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
FFX
System, Gastrointestinal Motility (electrical)
90d
Cleared
Nov 05, 1999
COLDLIGHTSOURCE PL3000
FCW
Light Source, Fiberoptic, Routine
35d
Cleared
Nov 05, 1999
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
23d
Cleared
Nov 04, 1999
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
KDN
System, Perfusion, Kidney
283d
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 27, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
FIE
Needle, Fistula
82d
Cleared
Oct 22, 1999
DRYASOL ACID CONCENTRATE MIX
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
28d
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