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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8376 Gastroenterology & Urology devices
Cleared
Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
261d
Cleared
Jan 10, 2018
Swiss LithoClast Trilogy
FEO
Lithotriptor, Ultrasonic
97d
Cleared
Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
LJE
Catheter, Nephrostomy
107d
Cleared
Jan 10, 2018
Instalief
LKX
Device, Thermal, Hemorrhoids
160d
Cleared
Jan 08, 2018
invendoscopy E210 System
FDF
Colonoscope And Accessories, Flexible/rigid
101d
Cleared
Jan 05, 2018
AquaShield System CO2- Fujifilm
FEQ
Pump, Air, Non-manual, For Endoscope
38d
Cleared
Jan 05, 2018
EON Portable Reverse Osmosis Water Purification System
FIP
Subsystem, Water Purification
267d
Cleared
Dec 29, 2017
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDX
Endoscopic Cytology Brush
213d
Cleared
Dec 28, 2017
UroLift System (UL400 and UL500)
PEW
Implantable Transprostatic Tissue Retractor System
90d
Not Cleared
Dec 22, 2017
remOVE System
QAG
Endoscopic Electrosurgical Clip Cutting System
620d
Cleared
Dec 21, 2017
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
EYB
Catheter, Ureteral, Gastro-urology
258d
Not Cleared
Dec 21, 2017
AQUABEAM System
PZP
Fluid Jet Removal System
248d
Cleared
Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
PWJ
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
117d
Cleared
Dec 19, 2017
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
FAJ
Cystoscope And Accessories, Flexible/rigid
271d
Cleared
Dec 15, 2017
Strange Bile Duct Stone Exploration Set
LQR
Dislodger, Stone, Biliary
14d
Cleared
Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
KOC
Accessories, Blood Circuit, Hemodialysis
141d
Cleared
Dec 13, 2017
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
142d
Cleared
Dec 13, 2017
SAM CRRT Unit, SAM Cassette CRRT
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
272d
Cleared
Dec 12, 2017
Pure-Vu System
FDF
Colonoscope And Accessories, Flexible/rigid
43d
Cleared
Dec 12, 2017
Sterile Endoscope Biopsy Sampling Needle
FCG
Biopsy Needle
166d
Cleared
Dec 12, 2017
Wittich Nitinol Stone Basket
LQR
Dislodger, Stone, Biliary
260d
Cleared
Dec 07, 2017
Single Use Electrosurgical Snare SD-400
FDI
Snare, Flexible
87d
Cleared
Dec 07, 2017
Cystoscope 4.0mm autoclavable 0° WL 302mm
FAJ
Cystoscope And Accessories, Flexible/rigid
213d
Cleared
Nov 30, 2017
NexSite HD, Hemodialysis Step Tip Catheter (60cm)
MSD
Catheter, Hemodialysis, Implanted
184d
Cleared
Nov 27, 2017
Single Use Retrieval Nitinol Basket V
LQR
Dislodger, Stone, Biliary
255d
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