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
8425 Gastroenterology & Urology devices
Cleared
Jun 03, 2003
NANMA VACUUM PUMP
LKY
Device, External Penile Rigidity
71d
Cleared
May 30, 2003
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
EZL
Catheter, Retention Type, Balloon
77d
Cleared
May 30, 2003
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
FGE
Stents, Drains And Dilators For The Biliary Ducts
74d
Cleared
May 30, 2003
FRESENIUS ULTRAFLUX HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
29d
Cleared
May 28, 2003
WATER PURIFICATION SYSTEM
FIP
Subsystem, Water Purification
306d
Cleared
May 23, 2003
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
137d
Cleared
May 23, 2003
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
87d
Cleared
May 23, 2003
DEFLECTING URETERAL ACCESS SHEATH
FED
Endoscopic Access Overtube, Gastroenterology-urology
84d
Cleared
May 23, 2003
AMSURE FOLEY INSERTION TRAY
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
81d
Cleared
May 23, 2003
AMSURE URETHRAL CATHETERIZATION TRAY
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
78d
Cleared
May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
FED
Endoscopic Access Overtube, Gastroenterology-urology
57d
Cleared
May 23, 2003
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
32d
Cleared
May 23, 2003
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
KNW
Instrument, Biopsy
24d
Cleared
May 22, 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
MNW
Analyzer, Body Composition
442d
Cleared
May 22, 2003
MODIFICATION TO FOSSA URETERAL STONE SWEEPER
FAD
Stent, Ureteral
29d
Cleared
May 21, 2003
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
FAS
Electrode, Electrosurgical, Active, Urological
51d
Cleared
May 20, 2003
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
90d
Cleared
May 20, 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
MSD
Catheter, Hemodialysis, Implanted
90d
Cleared
May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
22d
Cleared
May 13, 2003
INBODY AP1 BODY COMPOSITION ANALYZER
MNW
Analyzer, Body Composition
209d
Cleared
May 13, 2003
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
MPB
Catheter, Hemodialysis, Non-implanted
112d
Cleared
May 09, 2003
DIATEK CANNON-CATHETER, MODEL CC5500
MSD
Catheter, Hemodialysis, Implanted
273d
Cleared
May 09, 2003
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
KNW
Instrument, Biopsy
87d
Cleared
May 06, 2003
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
MSF
Hemodialyzer, Re-use, High Flux
190d
Cleared
May 06, 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
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