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
8414 Gastroenterology & Urology devices
Cleared
May 30, 2008
BARD E LUMINEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
555d
Cleared
May 20, 2008
XTJF TYPE Q160VF1
FDT
Duodenoscope And Accessories, Flexible/rigid
96d
Cleared
May 20, 2008
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
47d
Cleared
May 16, 2008
AUTO-BAND LIGATOR
MND
Ligator, Esophageal
24d
Cleared
May 14, 2008
MPS ACACIA ENTERAL FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
97d
Cleared
May 13, 2008
GRADUATED ADAPTER WITH CLAVE
EZD
Catheter, Straight
132d
Cleared
May 13, 2008
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
90d
Cleared
May 09, 2008
EVOLUTION ESOPHAGEAL STENT SYSTEM
ESW
Prosthesis, Esophageal
88d
Cleared
May 08, 2008
DESARA MESH SLING, MODEL CAL-DS01
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
251d
Cleared
May 06, 2008
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
FED
Endoscopic Access Overtube, Gastroenterology-urology
119d
Cleared
May 06, 2008
OLYMPUS XCHF TYPE B180Y1
FBN
Choledochoscope And Accessories, Flexible/rigid
64d
Cleared
May 06, 2008
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
54d
Cleared
May 06, 2008
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
ODC
Endoscope Channel Accessory
49d
Cleared
May 02, 2008
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
FDF
Colonoscope And Accessories, Flexible/rigid
24d
Cleared
Apr 29, 2008
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL
FDF
Colonoscope And Accessories, Flexible/rigid
83d
Cleared
Apr 24, 2008
ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
ESW
Prosthesis, Esophageal
30d
Cleared
Apr 11, 2008
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
199d
Cleared
Apr 11, 2008
CORAMATE/SPIROTOME SYSTEM
KNW
Instrument, Biopsy
88d
Cleared
Apr 09, 2008
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
FER
Anoscope And Accessories
82d
Cleared
Apr 09, 2008
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
ODA
Endoscopic Central Control Unit
55d
Cleared
Apr 07, 2008
CRYOSTAT
LKX
Device, Thermal, Hemorrhoids
223d
Cleared
Mar 26, 2008
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
OCW
Endoscopic Tissue Approximation Device
90d
Cleared
Mar 25, 2008
SMALL INTESTINAL VIDEOSCOPE SYSTEM
FDA
Enteroscope And Accessories
326d
Cleared
Mar 21, 2008
MANDREL GUIDEWIRES OR M-WIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
25d
Cleared
Mar 20, 2008
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
MNW
Analyzer, Body Composition
126d
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