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
2296 Gastroenterology & Urology devices
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
Cleared
Nov 14, 2018
HPM-6000UF
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
160d
Cleared
Nov 13, 2018
Aspire Venting Tube
KNT
Tubes, Gastrointestinal (and Accessories)
85d
Cleared
Nov 09, 2018
Enteral Feeding Syringes with Enfit Connectors
PNR
Enteral Syringes With Enteral Specific Connectors
46d
Cleared
Nov 08, 2018
MiroCam Capsule Endoscope System
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
233d
Cleared
Nov 06, 2018
ERBEFLO Olympus Scope Port Connector
OCX
Endoscopic Irrigation/suction System
60d
Cleared
Nov 06, 2018
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
FAD
Stent, Ureteral
258d
Not Cleared
Nov 06, 2018
Innovo
QAJ
Cutaneous Electrode Stimulator For Urinary Incontinence
414d
Cleared
Nov 05, 2018
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
GBM
Catheter, Urethral
222d
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