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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5367 Gastroenterology & Urology devices
Cleared
Oct 06, 2015
AXIOS Stent and Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
27d
Cleared
Oct 01, 2015
EPX-4440HD and EPX-4400HD with FICE
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
244d
Cleared
Sep 30, 2015
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Sep 24, 2015
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
59d
Cleared
Sep 03, 2015
Peristeen Anal Irrigation System
KNT
Tubes, Gastrointestinal (and Accessories)
573d
Cleared
Aug 25, 2015
BioGuard Air/Water Valve, BioGuard Suction Valve
ODC
Endoscope Channel Accessory
98d
Cleared
Aug 20, 2015
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
101d
Cleared
Aug 20, 2015
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
FDA
Enteroscope And Accessories
248d
Cleared
Aug 14, 2015
Sertera Biopsy Device
KNW
Instrument, Biopsy
200d
Cleared
Aug 07, 2015
Corvocet Coaxial Introducer
FCG
Biopsy Needle
78d
Cleared
Aug 06, 2015
Resolution Clip
PKL
Hemostatic Metal Clip For The Gi Tract
35d
Cleared
Aug 05, 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
140d
Cleared
Jul 30, 2015
Infinity ERCP Sampling Device
FDX
Endoscopic Cytology Brush
20d
Cleared
Jul 30, 2015
Polypectomy Snare
FDI
Snare, Flexible
171d
Cleared
Jul 28, 2015
Bard LubriGuard Foley Catheter
EZL
Catheter, Retention Type, Balloon
132d
Cleared
Jul 24, 2015
Medline ENFit Connectors
PIO
Enteral Specific Transition Connectors
37d
Cleared
Jul 13, 2015
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
179d
Cleared
Jul 06, 2015
Lariat snare
FDI
Snare, Flexible
62d
Cleared
Jul 06, 2015
FUJIFILM Endoscope Models EC-600HL and EC-600LS
FDF
Colonoscope And Accessories, Flexible/rigid
189d
Cleared
Jul 02, 2015
SpeediCath Compact Eve
GBM
Catheter, Urethral
86d
Cleared
Jun 04, 2015
NxStage System One
ODN
Ultrafiltration-controlled Nocturnal Dialysate Delivery System
101d
Cleared
Jun 02, 2015
Injection Needle
FBK
Endoscopic Injection Needle, Gastroenterology-urology
103d
Cleared
Jun 01, 2015
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
357d
Cleared
May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
73d
Cleared
May 27, 2015
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
OCY
Endoscopic Guidewire, Gastroenterology-urology
51d
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