FDA 510(k) Gastroenterology & Urology Devices
About Gastroenterology & Urology Devices
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
9824
Total
9777
Cleared
130d
Avg days
1976
Since
609 Gastroenterology & Urology devices
Cleared
Nov 01, 2024
SC+ Hemodialysis Device (SC-14269)
ONW
Hemodialysis System For Home Use
92d
Cleared
Nov 01, 2024
AMT Low-Profile Suprapubic Catheter & Drainage Set
KOB
Catheter, Suprapubic (and Accessories)
253d
Cleared
Oct 30, 2024
NeurAxis IB-Stim (01-1020)
QHH
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
153d
Cleared
Oct 30, 2024
MedicCO2LON (MedicCO2LON)
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
217d
Not Cleared
Oct 30, 2024
Stone Clear (SC-LP9-01)
QNA
Ultrasonic Urinary Stone Propulsion Device
328d
Cleared
Oct 25, 2024
CORGRIP* SR NG/NI Tube Retention System
KNT
Tubes, Gastrointestinal (and Accessories)
179d
Cleared
Oct 23, 2024
KIDNEYvault Portable Renal Perfusion System
KDN
System, Perfusion, Kidney
306d
Cleared
Oct 22, 2024
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
145d
Cleared
Oct 18, 2024
Altis Single Incision Sling System (519650)
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
59d
Cleared
Oct 16, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
FAJ
Cystoscope And Accessories, Flexible/rigid
203d
Cleared
Oct 15, 2024
Single-use Extraction Baskets
LQR
Dislodger, Stone, Biliary
265d
Cleared
Oct 11, 2024
Hood (DH-083ST)
FDS
Gastroscope And Accessories, Flexible/rigid
28d
Cleared
Oct 11, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
ODC
Endoscope Channel Accessory
30d
Cleared
Oct 10, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
FAJ
Cystoscope And Accessories, Flexible/rigid
197d
Cleared
Oct 08, 2024
Single-use Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
260d
Cleared
Oct 07, 2024
Water Container (MAJ-901)
OCX
Endoscopic Irrigation/suction System
60d
Cleared
Oct 04, 2024
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
FDF
Colonoscope And Accessories, Flexible/rigid
59d
Cleared
Oct 04, 2024
Video Ureteroscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
136d
Cleared
Oct 04, 2024
Endoscopic Injection Needles
FBK
Endoscopic Injection Needle, Gastroenterology-urology
207d
Cleared
Oct 04, 2024
Single use flexible ureteroscope (UR-D1)
FGB
Ureteroscope And Accessories, Flexible/rigid
268d
Cleared
Oct 01, 2024
Disposable Endoscope Valves Set (AF series)
ODC
Endoscope Channel Accessory
147d
Cleared
Sep 30, 2024
AQUABEAM Robotic System (AB2000)
PZP
Fluid Jet Removal System
89d
Cleared
Sep 24, 2024
Aspiration Catheter (2189)
OCX
Endoscopic Irrigation/suction System
88d
Cleared
Sep 18, 2024
InnoCare Specialty Foley Catheter
EZL
Catheter, Retention Type, Balloon
121d
Cleared
Sep 17, 2024
PADLOCK CLIP EFTR Kit (00713229)
PKL
Hemostatic Metal Clip For The Gi Tract
230d
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