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
8420 Gastroenterology & Urology devices
Cleared
May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
79d
Cleared
May 16, 2005
ENCOR 7 GAUGE
KNW
Instrument, Biopsy
11d
Cleared
May 12, 2005
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
FCG
Biopsy Needle
73d
Cleared
May 11, 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
174d
Cleared
May 06, 2005
ANTI-I.V. ENTERAL FEEDING SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
183d
Cleared
May 05, 2005
90XL INSTRUMENTATION SYSTEM
FIZ
Meter, Conductivity, Non-remote
35d
Cleared
May 05, 2005
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
GBM
Catheter, Urethral
29d
Cleared
Apr 28, 2005
NITI-S STENT & INTRODUCER, MODEL EOXXXX
ESW
Prosthesis, Esophageal
315d
Cleared
Apr 22, 2005
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
46d
Cleared
Apr 22, 2005
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
FGE
Stents, Drains And Dilators For The Biliary Ducts
25d
Cleared
Apr 20, 2005
PROTEGE GPS SELF-EXPANDING NITINOL STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Apr 15, 2005
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
FIP
Subsystem, Water Purification
262d
Cleared
Apr 12, 2005
EVADRI BLADDER CONTROL SYSTEMS
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
47d
Cleared
Apr 08, 2005
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
135d
Cleared
Apr 06, 2005
TEGRESS IMPLANT NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
20d
Cleared
Apr 04, 2005
AIDA WITH DICOM AND HL7 INTERFACE
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
123d
Cleared
Apr 01, 2005
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
FAS
Electrode, Electrosurgical, Active, Urological
35d
Cleared
Mar 31, 2005
FRESENIUS LIBERTY CYCLER
FKX
System, Peritoneal, Automatic Delivery
114d
Cleared
Mar 31, 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
FED
Endoscopic Access Overtube, Gastroenterology-urology
108d
Cleared
Mar 31, 2005
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
92d
Cleared
Mar 31, 2005
COOK IRELAND SONNET POLYPECTOMY SNARE
FDI
Snare, Flexible
52d
Cleared
Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
13d
Cleared
Mar 23, 2005
14F DUAL FLOATING DIALYSIS CATHETER/TRAY
MSD
Catheter, Hemodialysis, Implanted
175d
Cleared
Mar 23, 2005
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
FIP
Subsystem, Water Purification
107d
Cleared
Mar 22, 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
FGE
Stents, Drains And Dilators For The Biliary Ducts
11d
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