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
Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
FCG
Biopsy Needle
21d
Cleared
Feb 04, 2005
INSCOPE 3-STAGE BALLOON DILATOR
KNQ
Dilator, Esophageal
36d
Cleared
Feb 03, 2005
MEDCOMP SPLIT-CATH II
MSD
Catheter, Hemodialysis, Implanted
360d
Cleared
Feb 03, 2005
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
FAJ
Cystoscope And Accessories, Flexible/rigid
120d
Cleared
Feb 03, 2005
ASSIST HEADER CLEANER
LIF
Dialyzer Reprocessing System
83d
Cleared
Feb 01, 2005
UPDATED SLIP UROLOGY INTRODUCER SHEATH
KNY
Accessories, Catheter, G-u
137d
Cleared
Jan 28, 2005
INFANT FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
176d
Cleared
Jan 28, 2005
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
FDF
Colonoscope And Accessories, Flexible/rigid
42d
Cleared
Jan 25, 2005
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
NON
Forceps, Biopsy, Non-electric, Reprocessed
124d
Cleared
Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
MNW
Analyzer, Body Composition
75d
Cleared
Jan 18, 2005
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
110d
Cleared
Jan 11, 2005
INBODY, MODEL 3.0
MNW
Analyzer, Body Composition
116d
Cleared
Jan 06, 2005
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
73d
Cleared
Dec 30, 2004
BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
FAD
Stent, Ureteral
454d
Cleared
Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
14d
Cleared
Dec 23, 2004
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
MNW
Analyzer, Body Composition
272d
Cleared
Dec 23, 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
55d
Cleared
Dec 23, 2004
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
GBM
Catheter, Urethral
30d
Cleared
Dec 22, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
MSD
Catheter, Hemodialysis, Implanted
26d
Cleared
Dec 20, 2004
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
27d
Cleared
Dec 17, 2004
CORTRAK
KNT
Tubes, Gastrointestinal (and Accessories)
147d
Cleared
Dec 16, 2004
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
KNT
Tubes, Gastrointestinal (and Accessories)
22d
Cleared
Dec 14, 2004
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
82d
Cleared
Dec 10, 2004
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
Dec 09, 2004
PRIMUS STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
16d
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