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
2287 Gastroenterology & Urology devices
Cleared
Aug 30, 2023
Enzyme Packed Cartridge - RELiZORB
PLQ
Enzyme Packed Cartridge
128d
Cleared
Aug 30, 2023
AquaBeam Robotic System
PZP
Fluid Jet Removal System
141d
Cleared
Aug 28, 2023
Precision GI
FCG
Biopsy Needle
103d
Cleared
Aug 25, 2023
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
EZD
Catheter, Straight
217d
Cleared
Aug 18, 2023
Automatic Continuous Effusion Shunt (ACES) System ACES System
KPM
Shunt, Peritoneal
122d
Not Cleared
Aug 18, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)
QXH
Gallbladder Drainage Stent And Delivery System
144d
Cleared
Aug 17, 2023
Aer-O-Scope Colonoscope System
FDF
Colonoscope And Accessories, Flexible/rigid
168d
Cleared
Aug 17, 2023
Feeding Tube
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
337d
Cleared
Aug 17, 2023
Oral/Enteral Syringe with ENFit connector
PNR
Enteral Syringes With Enteral Specific Connectors
337d
Cleared
Aug 16, 2023
AQUAbase nX
FIP
Subsystem, Water Purification
271d
Not Cleared
Aug 16, 2023
Revi System
QXM
Implanted Tibial Electrical Urinary Continence Device
315d
Cleared
Aug 15, 2023
BAROguard
KDN
System, Perfusion, Kidney
235d
Cleared
Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
24d
Cleared
Aug 14, 2023
ENDOGATOR™ Hybrid Irrigation Tubing
OCX
Endoscopic Irrigation/suction System
90d
Cleared
Aug 11, 2023
VersiHD with GuideMe software
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
157d
Cleared
Aug 04, 2023
Citric Complete Liquid Citric Acid Concentrate
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
263d
Cleared
Aug 02, 2023
Disposable Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
138d
Cleared
Aug 02, 2023
Self-Cath Closed System
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
224d
Cleared
Aug 01, 2023
Protego Air Water Connector
OCX
Endoscopic Irrigation/suction System
61d
Cleared
Jul 31, 2023
Disposable Hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
209d
Cleared
Jul 31, 2023
RenaNav Ureteroscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
304d
Cleared
Jul 28, 2023
Blood Tubing Lines for Hemodialysis AV06C-E
KOC
Accessories, Blood Circuit, Hemodialysis
57d
Cleared
Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
88d
Cleared
Jul 28, 2023
Pathfinder Endoscope Overtube with Balloon Device
FED
Endoscopic Access Overtube, Gastroenterology-urology
127d
Cleared
Jul 27, 2023
Teleflex Rusch SoftSimplastic Foley Catheters
EZL
Catheter, Retention Type, Balloon
755d
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