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
2285 Gastroenterology & Urology devices
Cleared
Mar 27, 2025
Levina Pelvic Floor Muscle Stimulator (RS-48)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
273d
Cleared
Mar 26, 2025
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
KDN
System, Perfusion, Kidney
103d
Cleared
Mar 26, 2025
SB Knife Jr2 (MD-47702 and MD-47702L)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
272d
Cleared
Mar 24, 2025
Glean Urodynamics System Male Delivery System (GUS-1000-M)
EXQ
Cystometer, Electrical Recording
178d
Cleared
Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
FED
Endoscopic Access Overtube, Gastroenterology-urology
28d
Cleared
Mar 21, 2025
EHL Probe (SCDG-AS)
FFK
Lithotriptor, Electro-hydraulic
175d
Cleared
Mar 21, 2025
Electrohydraulic Lithotriptor (TCS-B3-II)
FFK
Lithotriptor, Electro-hydraulic
179d
Cleared
Mar 21, 2025
FX CorAL 40 (F00009214)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
252d
Cleared
Mar 20, 2025
Endoscopic Water Pump
OCX
Endoscopic Irrigation/suction System
280d
Cleared
Mar 19, 2025
Luer-Split MAJ-2092
ODC
Endoscope Channel Accessory
266d
Cleared
Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
LQR
Dislodger, Stone, Biliary
97d
Cleared
Mar 17, 2025
UPT Series Medical RO Water Treatment System
FIP
Subsystem, Water Purification
24d
Cleared
Mar 07, 2025
Flexible Video-Choledochoscope (CHV-110J-U)
FBN
Choledochoscope And Accessories, Flexible/rigid
112d
Cleared
Mar 05, 2025
Wellead® Hydrophilic Intermittent Catheter Ready to Use
GBM
Catheter, Urethral
261d
Cleared
Feb 28, 2025
FX CorAL 60 (F00012969)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
73d
Cleared
Feb 27, 2025
Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
KNW
Instrument, Biopsy
223d
Cleared
Feb 20, 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
ODC
Endoscope Channel Accessory
34d
Cleared
Feb 12, 2025
Fecobionics Anorectal System
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
160d
Cleared
Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
FGB
Ureteroscope And Accessories, Flexible/rigid
134d
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
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