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
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
Cleared
Nov 02, 2018
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
MQR
Stent, Colonic, Metallic, Expandable
283d
Cleared
Nov 01, 2018
Spectra Optia Apheresis System
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
195d
Cleared
Nov 01, 2018
Clear-Tip EUS-FNA
FCG
Biopsy Needle
265d
Cleared
Oct 31, 2018
Single Use Aspiration Needle NA-U201H
FCG
Biopsy Needle
97d
Cleared
Oct 30, 2018
DiLumen Endolumenal Interventional Platform
FDF
Colonoscope And Accessories, Flexible/rigid
46d
Cleared
Oct 30, 2018
Wilson-Cook Mini Basket
LQR
Dislodger, Stone, Biliary
60d
Cleared
Oct 30, 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
KOB
Catheter, Suprapubic (and Accessories)
90d
Cleared
Oct 30, 2018
UroGen Ureteral Catheter
KOD
Catheter, Urological
264d
Cleared
Oct 26, 2018
PENTAX Medical Video Colonoscope EC34-i10T Series
FDF
Colonoscope And Accessories, Flexible/rigid
267d
Cleared
Oct 25, 2018
SpeediCath Standard
GBM
Catheter, Urethral
268d
Cleared
Oct 24, 2018
GastroFlush
KNT
Tubes, Gastrointestinal (and Accessories)
231d
Cleared
Oct 23, 2018
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
KNT
Tubes, Gastrointestinal (and Accessories)
228d
Cleared
Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
MSB
System And Accessories, Isolated Heart, Transport And Preservation
21d
Cleared
Oct 18, 2018
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
213d
Cleared
Oct 17, 2018
Uroject12 Syringe Lever
QBL
Piston Syringe Lever
251d
Cleared
Oct 15, 2018
Reliant(TM) Multistage Dilatation Balloon Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
242d
Cleared
Oct 12, 2018
PENTAX Video Upper G.I. Scope EG34-i10
FDS
Gastroscope And Accessories, Flexible/rigid
253d
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