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
5365 Gastroenterology & Urology devices
Cleared
Jan 18, 2019
PENTAX Video Colonoscopes (EC Family)
FDF
Colonoscope And Accessories, Flexible/rigid
269d
Cleared
Jan 18, 2019
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FPD
Tube, Feeding
354d
Cleared
Jan 16, 2019
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
FGB
Ureteroscope And Accessories, Flexible/rigid
229d
Cleared
Jan 16, 2019
Dosis SAM
MQS
System, Hemodialysis, Access Recirculation Monitoring
336d
Cleared
Jan 10, 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
MQR
Stent, Colonic, Metallic, Expandable
15d
Cleared
Jan 10, 2019
Signal Catheter
EZL
Catheter, Retention Type, Balloon
108d
Cleared
Jan 10, 2019
DIASAFEplusUS
FIP
Subsystem, Water Purification
132d
Cleared
Jan 03, 2019
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
PTE
Endoscopic Morcellator Gastroenterology
248d
Cleared
Dec 26, 2018
One-Step Suprapubic Introducer
KOB
Catheter, Suprapubic (and Accessories)
90d
Cleared
Dec 21, 2018
Clear-Jet Injection Catheter
FBK
Endoscopic Injection Needle, Gastroenterology-urology
178d
Not Cleared
Dec 20, 2018
SEM Scanner (Model 200)
QEF
Pressure Ulcer Management Tool
626d
Cleared
Dec 18, 2018
ValPro 2 Plus, VaPro 2 Plus Pocket
GBM
Catheter, Urethral
27d
Cleared
Dec 18, 2018
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
FCG
Biopsy Needle
169d
Cleared
Dec 14, 2018
SureClip Repositionable Hemostasis Clip
PKL
Hemostatic Metal Clip For The Gi Tract
88d
Cleared
Dec 07, 2018
FiXcision
KOA
Surgical Instruments, G-u, Manual (and Accessories)
73d
Cleared
Dec 07, 2018
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
267d
Cleared
Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
271d
Cleared
Nov 27, 2018
AdVance XP Male Sling
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
109d
Cleared
Nov 23, 2018
Greene Renal Transplant Stent Set
FAD
Stent, Ureteral
267d
Cleared
Nov 21, 2018
Roth Net Retriever Product Line
FDI
Snare, Flexible
35d
Cleared
Nov 20, 2018
Telepack X LED
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
54d
Cleared
Nov 16, 2018
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
18d
Cleared
Nov 16, 2018
SmartBag (SmartPouch)
EXB
Collector, Ostomy
147d
Cleared
Nov 15, 2018
SITZMARKS
FFX
System, Gastrointestinal Motility (electrical)
136d
Cleared
Nov 15, 2018
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
FCG
Biopsy Needle
246d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices