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
617 Gastroenterology & Urology devices
Cleared
May 20, 2021
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
FCG
Biopsy Needle
90d
Cleared
May 19, 2021
Electrosurgical accessory
FAS
Electrode, Electrosurgical, Active, Urological
98d
Cleared
May 13, 2021
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
FDS
Gastroscope And Accessories, Flexible/rigid
83d
Cleared
May 06, 2021
AutoCap RX
ODC
Endoscope Channel Accessory
87d
Cleared
Apr 28, 2021
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
GEX
Powered Laser Surgical Instrument
30d
Cleared
Apr 27, 2021
Safety Trocar Cannula
KNT
Tubes, Gastrointestinal (and Accessories)
15d
Cleared
Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
FAD
Stent, Ureteral
448d
Cleared
Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
178d
Cleared
Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
FDT
Duodenoscope And Accessories, Flexible/rigid
30d
Cleared
Apr 09, 2021
Endoscope Model EI-740D/S
FDS
Gastroscope And Accessories, Flexible/rigid
78d
Cleared
Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
FDT
Duodenoscope And Accessories, Flexible/rigid
225d
Cleared
Mar 15, 2021
Ensure Single-Use Coagulation Forceps
KGE
Forceps, Biopsy, Electric
202d
Cleared
Feb 25, 2021
Vortek Single Loop Ureteral Stent
FAD
Stent, Ureteral
269d
Cleared
Jan 14, 2021
Lockado Repositionable Hemostasis Clip
PKL
Hemostatic Metal Clip For The Gi Tract
150d
Cleared
Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
ODC
Endoscope Channel Accessory
169d
Cleared
Jan 13, 2021
MyOnyx System
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
271d
Cleared
Jan 06, 2021
Applied Medical Anoscope
FER
Anoscope And Accessories
366d
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