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
607 Gastroenterology & Urology devices
Cleared
Sep 19, 2025
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
FDT
Duodenoscope And Accessories, Flexible/rigid
94d
Cleared
Sep 19, 2025
IPGTFL-02
GEX
Powered Laser Surgical Instrument
162d
Cleared
Sep 19, 2025
Single Use Suction-Evacuation Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
245d
Cleared
Sep 19, 2025
Purema H Hemoconcentrator - Pediatric
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
273d
Cleared
Sep 15, 2025
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
FAJ
Cystoscope And Accessories, Flexible/rigid
28d
Cleared
Sep 12, 2025
CADDIE
QNP
Gastrointesinal Lesion Software Detection System
28d
Cleared
Sep 12, 2025
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
FBN
Choledochoscope And Accessories, Flexible/rigid
150d
Cleared
Sep 11, 2025
UV5000 Handle
FAJ
Cystoscope And Accessories, Flexible/rigid
181d
Cleared
Sep 09, 2025
AquaA
FIP
Subsystem, Water Purification
60d
Cleared
Sep 09, 2025
Bicarby Dialysate RFP-404 (RFP-404-W)
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
60d
Cleared
Sep 08, 2025
Dual Action Tissue Closure Device
PKL
Hemostatic Metal Clip For The Gi Tract
224d
Cleared
Sep 05, 2025
Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
231d
Cleared
Aug 29, 2025
Regenesis EMS Chair
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
149d
Cleared
Aug 26, 2025
Medical Video Endoscope [Standard Deflection] (URS3005)
FGB
Ureteroscope And Accessories, Flexible/rigid
228d
Cleared
Aug 21, 2025
ClearTip FNA and FNB Types
FCG
Biopsy Needle
142d
Cleared
Aug 20, 2025
EndoFix™Tissue Fixation System
FGE
Stents, Drains And Dilators For The Biliary Ducts
121d
Cleared
Aug 15, 2025
JMS CAVEO A.V. Fistula Needle Set
FIE
Needle, Fistula
58d
Cleared
Aug 13, 2025
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101)
NQJ
Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use
28d
Cleared
Aug 13, 2025
KARL STORZ HOPKINS Telescopes for Urology
FAJ
Cystoscope And Accessories, Flexible/rigid
260d
Cleared
Aug 12, 2025
14F Duo-Flow® Side X Side Double Lumen Catheter
MPB
Catheter, Hemodialysis, Non-implanted
145d
Cleared
Aug 08, 2025
Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
FAJ
Cystoscope And Accessories, Flexible/rigid
28d
Cleared
Aug 08, 2025
Aqua Medical RF Vapor Ablation System
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
109d
Cleared
Aug 01, 2025
AK 98 Dialysis Machine (955607)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
161d
Cleared
Jul 23, 2025
Resilience Fully Covered Esophageal Stent System
ESW
Prosthesis, Esophageal
90d
Cleared
Jul 22, 2025
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
PBP
Rectal Insert
265d
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