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
May 15, 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
296d
Cleared
May 14, 2025
Disposable ureteral stent
FAD
Stent, Ureteral
152d
Cleared
May 09, 2025
SKOUT system
QNP
Gastrointesinal Lesion Software Detection System
28d
Cleared
May 06, 2025
Single-use Flexible Ureteroscope
FGB
Ureteroscope And Accessories, Flexible/rigid
53d
Cleared
May 05, 2025
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
MLW
Warmer, Peritoneal Dialysate
445d
Cleared
May 02, 2025
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1)
FBO
Cystourethroscope
127d
Cleared
May 02, 2025
F88 URE-SD/RD Flexible Ureteroscope
FGB
Ureteroscope And Accessories, Flexible/rigid
135d
Cleared
May 01, 2025
Disposable Distal Attachment D-201 Series
FDS
Gastroscope And Accessories, Flexible/rigid
90d
Cleared
May 01, 2025
X°Port Lung Preservation System
KDN
System, Perfusion, Kidney
135d
Cleared
Apr 29, 2025
PUMA-G Pediatric System
KGC
Tube, Gastro-enterostomy
274d
Cleared
Apr 28, 2025
LumiRex Ureteroscope
FGB
Ureteroscope And Accessories, Flexible/rigid
164d
Cleared
Apr 25, 2025
DCX Disposable Cassette (DCX)
KDN
System, Perfusion, Kidney
120d
Cleared
Apr 25, 2025
DHF 0.2 Hemoconcentrator (DHF 02)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
192d
Cleared
Apr 23, 2025
EchoGuide (Version 1)
IYO
System, Imaging, Pulsed Echo, Ultrasonic
166d
Cleared
Apr 18, 2025
PADLOCK CLIP EFTR Kit (00713229)
PKL
Hemostatic Metal Clip For The Gi Tract
29d
Cleared
Apr 18, 2025
Extension Feeding Set with ENFit™ Connectors
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
58d
Cleared
Apr 17, 2025
RELiZORB (100300/100301)
PLQ
Enzyme Packed Cartridge
56d
Cleared
Apr 17, 2025
Luja Set
EZD
Catheter, Straight
77d
Cleared
Apr 17, 2025
SimpleStitch Suturing System
OCW
Endoscopic Tissue Approximation Device
133d
Cleared
Apr 15, 2025
Percuflex Ureteral Stent
FAD
Stent, Ureteral
28d
Cleared
Apr 11, 2025
Chlorine Sentinel II
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
113d
Cleared
Apr 11, 2025
Flexible Ureterorenoscope (US27F-12-EU
FGB
Ureteroscope And Accessories, Flexible/rigid
116d
Cleared
Apr 11, 2025
Disposable ureteral access sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
130d
Cleared
Apr 11, 2025
FUJIFILM Processor EP-8000
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
178d
Cleared
Apr 10, 2025
XNY Disposable Gastric Calibration Tube
KNT
Tubes, Gastrointestinal (and Accessories)
58d
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