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
614 Gastroenterology & Urology devices
Cleared
Feb 02, 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
FGB
Ureteroscope And Accessories, Flexible/rigid
253d
Cleared
Jan 27, 2023
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
GEX
Powered Laser Surgical Instrument
267d
Cleared
Jan 20, 2023
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
FAJ
Cystoscope And Accessories, Flexible/rigid
224d
Cleared
Jan 19, 2023
HF-cables (resusable)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
238d
Cleared
Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
176d
Cleared
Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
25d
Cleared
Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Dec 29, 2022
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
129d
Cleared
Dec 29, 2022
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
FAJ
Cystoscope And Accessories, Flexible/rigid
202d
Cleared
Dec 16, 2022
multiFiltratePRO System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
318d
Cleared
Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
FAD
Stent, Ureteral
506d
Cleared
Oct 31, 2022
Fresenius Liberty Select Cycler
FKX
System, Peritoneal, Automatic Delivery
90d
Cleared
Oct 27, 2022
2008T BlueStar Hemodailysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Oct 03, 2022
Elastic Traction System
QSW
Endoscopic Traction Device
60d
Cleared
Sep 16, 2022
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
PNR
Enteral Syringes With Enteral Specific Connectors
58d
Cleared
Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
PKL
Hemostatic Metal Clip For The Gi Tract
27d
Cleared
Sep 08, 2022
HD-550 Video Endoscope System
NWB
Endoscope, Accessories, Narrow Band Spectrum
62d
Cleared
Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
237d
Cleared
Aug 29, 2022
Rusch Intermittent Urethral Catheters
EZC
Catheter, Coude
31d
Cleared
Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
112d
Cleared
Aug 11, 2022
Erbe's Tubing/Cap Sets
OCX
Endoscopic Irrigation/suction System
108d
Cleared
Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
30d
Cleared
Aug 04, 2022
MANTIS Clip
PKL
Hemostatic Metal Clip For The Gi Tract
108d
Cleared
Jul 27, 2022
Dornier Thulio
GEX
Powered Laser Surgical Instrument
300d
Cleared
Jun 13, 2022
Disposable Hemostatic Closure Clip Device
PKL
Hemostatic Metal Clip For The Gi Tract
145d
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