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
9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2289 Gastroenterology & Urology devices
Cleared
May 01, 2020
FUJIFILM EP-6000 Video Processor
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
253d
Not Cleared
Apr 29, 2020
CARPEDIEM System
QIR
Pediatric Hemodialysis System
568d
Cleared
Apr 28, 2020
Single Use Injector
FBK
Endoscopic Injection Needle, Gastroenterology-urology
230d
Cleared
Apr 24, 2020
Custodiol HTK Solution
KDL
Set, Perfusion, Kidney, Disposable
233d
Cleared
Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
270d
Cleared
Apr 23, 2020
Duo-Flow Side x Side Double Lumen Catheter
MPB
Catheter, Hemodialysis, Non-implanted
205d
Cleared
Apr 23, 2020
RocaTub Ureteral Catheter
EYB
Catheter, Ureteral, Gastro-urology
255d
Cleared
Apr 21, 2020
Lariat, Hot/Cold Snare
FDI
Snare, Flexible
29d
Cleared
Apr 21, 2020
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
EZL
Catheter, Retention Type, Balloon
266d
Cleared
Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
MQR
Stent, Colonic, Metallic, Expandable
74d
Cleared
Apr 16, 2020
EON Portable RO Water Purification System
FIP
Subsystem, Water Purification
34d
Cleared
Apr 15, 2020
G-EYE System
FDF
Colonoscope And Accessories, Flexible/rigid
209d
Cleared
Apr 14, 2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
OCX
Endoscopic Irrigation/suction System
56d
Cleared
Apr 08, 2020
Standard Bougie
KNT
Tubes, Gastrointestinal (and Accessories)
268d
Cleared
Apr 06, 2020
Irrigation Tubing with CO2 or Air
OCX
Endoscopic Irrigation/suction System
133d
Cleared
Apr 02, 2020
Ambu aScope 4 Cysto
FAJ
Cystoscope And Accessories, Flexible/rigid
147d
Cleared
Mar 31, 2020
Tablo Hemodialysis System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
8d
Cleared
Mar 31, 2020
AquaFlate Pre-Filled Sterile Water Syringe 10mL
EZL
Catheter, Retention Type, Balloon
28d
Cleared
Mar 27, 2020
Single Use Grasping Forceps
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
255d
Cleared
Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
156d
Cleared
Mar 13, 2020
PrisMax System Version 3
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
87d
Cleared
Mar 13, 2020
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
KNT
Tubes, Gastrointestinal (and Accessories)
102d
Cleared
Mar 12, 2020
AMT Suture Delivery System
KGC
Tube, Gastro-enterostomy
77d
Cleared
Mar 05, 2020
Instinct Plus Endoscopic Clipping Device
PKL
Hemostatic Metal Clip For The Gi Tract
161d
Cleared
Mar 05, 2020
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
MSD
Catheter, Hemodialysis, Implanted
367d
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