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
9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2290 Gastroenterology & Urology devices
Cleared
Nov 15, 2019
Dornier Ureteral Stent
FAD
Stent, Ureteral
276d
Cleared
Nov 14, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
FDX
Endoscopic Cytology Brush
30d
Cleared
Nov 13, 2019
AMICUS Separator System
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
96d
Cleared
Nov 12, 2019
PENTAX Medical Video Upper GI Scopes (EG Family)
FDS
Gastroscope And Accessories, Flexible/rigid
229d
Cleared
Nov 08, 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
179d
Cleared
Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
212d
Cleared
Nov 06, 2019
Silicone Foley Catheter
EZL
Catheter, Retention Type, Balloon
422d
Cleared
Nov 01, 2019
Perfect PFE
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
170d
Cleared
Oct 25, 2019
MiniCap Extended Life PD Transfer Sets
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
28d
Cleared
Oct 25, 2019
FILTRAY 2G Disposable Water Filters
NHV
System, Water Purification, General Medical Use
134d
Cleared
Oct 24, 2019
Padlock Clip defect closure system, Padlock Pro-Select defect closure device
PKL
Hemostatic Metal Clip For The Gi Tract
27d
Cleared
Oct 22, 2019
stentfix OTSC System Set
PKL
Hemostatic Metal Clip For The Gi Tract
327d
Cleared
Oct 21, 2019
PENTAX Medical ED-3490TK Video Duodenoscope
FDT
Duodenoscope And Accessories, Flexible/rigid
60d
Cleared
Oct 11, 2019
McLean-Ring Enteral Feeding Tube Set
KNT
Tubes, Gastrointestinal (and Accessories)
267d
Cleared
Oct 08, 2019
ScopeSeal Duodenoscope Protective Device
ODB
Endoscopic Contamination Prevention Sheath
326d
Cleared
Oct 04, 2019
Urethrotech UCD
EZL
Catheter, Retention Type, Balloon
266d
Cleared
Oct 03, 2019
Millenium HX
FIP
Subsystem, Water Purification
30d
Cleared
Oct 03, 2019
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
FFX
System, Gastrointestinal Motility (electrical)
241d
Cleared
Sep 30, 2019
Fidmi Low Profile Enteral Feeding Device
KGC
Tube, Gastro-enterostomy
83d
Cleared
Sep 27, 2019
FUJIFILM Duodenoscope Model ED-580XT
FDT
Duodenoscope And Accessories, Flexible/rigid
88d
Cleared
Sep 24, 2019
EasiSlush
KDN
System, Perfusion, Kidney
161d
Cleared
Sep 18, 2019
Flexible HD Cysto-Urethroscope System
FAJ
Cystoscope And Accessories, Flexible/rigid
120d
Cleared
Sep 18, 2019
Dornier MINNOW Ureteral Catheter
EYB
Catheter, Ureteral, Gastro-urology
138d
Cleared
Sep 17, 2019
Bio Guard Air/Water & Suction Valves
ODC
Endoscope Channel Accessory
47d
Cleared
Sep 06, 2019
Vacutore Air/Water Bottle Tubing
OCX
Endoscopic Irrigation/suction System
107d
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