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
614 Gastroenterology & Urology devices
Cleared
Sep 15, 2023
Ambu® aScope™ Colon
FDF
Colonoscope And Accessories, Flexible/rigid
220d
Cleared
Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Sep 08, 2023
Air/Water Bottle Tubing, CO2 Source Tubing
OCX
Endoscopic Irrigation/suction System
109d
Cleared
Sep 08, 2023
KARL STORZ Urological Laser Accessories
GEX
Powered Laser Surgical Instrument
193d
Cleared
Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
FDF
Colonoscope And Accessories, Flexible/rigid
261d
Cleared
Sep 06, 2023
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
FGE
Stents, Drains And Dilators For The Biliary Ducts
232d
Cleared
Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
FDS
Gastroscope And Accessories, Flexible/rigid
30d
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
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
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
Cleared
Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
24d
Cleared
Aug 11, 2023
VersiHD with GuideMe software
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
157d
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
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 27, 2023
Teleflex Rusch SoftSimplastic Foley Catheters
EZL
Catheter, Retention Type, Balloon
755d
Cleared
Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
FGB
Ureteroscope And Accessories, Flexible/rigid
29d
Cleared
Jul 21, 2023
EndoflipTM 300 System
FFX
System, Gastrointestinal Motility (electrical)
28d
Cleared
Jul 07, 2023
ANDORATE® Valve Kit
OCX
Endoscopic Irrigation/suction System
95d
Cleared
Jun 30, 2023
ClearTip
FCG
Biopsy Needle
59d
Cleared
Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
30d
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