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
Feb 11, 2025
MOR
QRC
Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation
228d
Cleared
Feb 10, 2025
BTL-398
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
257d
Cleared
Feb 07, 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
107d
Cleared
Feb 06, 2025
Resolution Clip (M00522600)
PKL
Hemostatic Metal Clip For The Gi Tract
27d
Cleared
Feb 06, 2025
Disposable Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
195d
Cleared
Jan 31, 2025
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
FED
Endoscopic Access Overtube, Gastroenterology-urology
50d
Cleared
Jan 30, 2025
Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
125d
Cleared
Jan 29, 2025
Digital Video Processor
FGB
Ureteroscope And Accessories, Flexible/rigid
121d
Cleared
Jan 24, 2025
MAGENTIQ-COLO (ME-APDS)
QNP
Gastrointesinal Lesion Software Detection System
28d
Cleared
Jan 24, 2025
OrganProtex HTK Solution
KDL
Set, Perfusion, Kidney, Disposable
266d
Cleared
Jan 22, 2025
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
FGB
Ureteroscope And Accessories, Flexible/rigid
203d
Cleared
Jan 21, 2025
Biliary Pancreaticobiliary Scope System
FBN
Choledochoscope And Accessories, Flexible/rigid
244d
Cleared
Jan 17, 2025
Teslatome Bipolar Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
60d
Cleared
Jan 17, 2025
Embozene Color-Advanced Microspheres
KRD
Device, Vascular, For Promoting Embolization
136d
Cleared
Jan 17, 2025
hygh-tec Drainage II
KNT
Tubes, Gastrointestinal (and Accessories)
163d
Cleared
Jan 15, 2025
RELiZORB (100300/ 100301)
PLQ
Enzyme Packed Cartridge
90d
Cleared
Jan 15, 2025
PuraStat
PHN
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
134d
Cleared
Jan 14, 2025
ASEPT® Glide Peritoneal Drainage System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
253d
Cleared
Jan 10, 2025
ZZIREN™ Orogastric Tube
KNT
Tubes, Gastrointestinal (and Accessories)
109d
Cleared
Jan 10, 2025
Triopsy Actuator (TMSDGB)
KNW
Instrument, Biopsy
164d
Cleared
Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
FDF
Colonoscope And Accessories, Flexible/rigid
168d
Cleared
Jan 02, 2025
Haemostasis Clips
PKL
Hemostatic Metal Clip For The Gi Tract
265d
Cleared
Dec 20, 2024
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
29d
Cleared
Dec 20, 2024
SimpleSnip Endoscopic Suture Cutter (SC500160)
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
87d
Cleared
Dec 20, 2024
Single-use Balloon Dilatation Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
175d
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