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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5362 Gastroenterology & Urology devices
Cleared
Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
178d
Cleared
Apr 13, 2021
Flyte
HIR
Perineometer
29d
Cleared
Apr 12, 2021
Athena Surgical RMUS System
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
89d
Cleared
Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
FDT
Duodenoscope And Accessories, Flexible/rigid
30d
Cleared
Apr 09, 2021
Endoscope Model EI-740D/S
FDS
Gastroscope And Accessories, Flexible/rigid
78d
Cleared
Apr 09, 2021
Enteral Feeding Catheter
KNT
Tubes, Gastrointestinal (and Accessories)
200d
Not Cleared
Apr 09, 2021
GI Genius
QNP
Gastrointesinal Lesion Software Detection System
213d
Cleared
Apr 08, 2021
Well Lead All Silicone Foley Catheter with Temperature Sensor
EZL
Catheter, Retention Type, Balloon
251d
Cleared
Apr 02, 2021
Pristine Long-Term Hemodialysis Catheter
MSD
Catheter, Hemodialysis, Implanted
100d
Cleared
Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
FDT
Duodenoscope And Accessories, Flexible/rigid
225d
Cleared
Mar 30, 2021
Modulith SLX-F2
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
348d
Cleared
Mar 24, 2021
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
KNT
Tubes, Gastrointestinal (and Accessories)
156d
Cleared
Mar 19, 2021
ZIDA Wearable Neuromodulation System
NAM
Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
539d
Cleared
Mar 15, 2021
Ensure Single-Use Coagulation Forceps
KGE
Forceps, Biopsy, Electric
202d
Cleared
Mar 11, 2021
AquaBeam Robotic System
PZP
Fluid Jet Removal System
162d
Cleared
Mar 10, 2021
NovaLine Tubing Sets for Hemodialysis
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
246d
Cleared
Mar 10, 2021
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
252d
Cleared
Mar 05, 2021
Andorate Universal Endoscope Tip Guard
OCU
Endoscopic Storage Cover
161d
Cleared
Feb 25, 2021
Vortek Single Loop Ureteral Stent
FAD
Stent, Ureteral
269d
Cleared
Feb 19, 2021
ClearCap Distal Attachment
OCX
Endoscopic Irrigation/suction System
163d
Cleared
Feb 18, 2021
EsoCheck Cell Collection Device
EOX
Esophagoscope (flexible Or Rigid)
30d
Cleared
Feb 05, 2021
Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
284d
Cleared
Jan 15, 2021
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
FGB
Ureteroscope And Accessories, Flexible/rigid
191d
Cleared
Jan 15, 2021
VMCore Biopsy Needle
KNW
Instrument, Biopsy
211d
Cleared
Jan 14, 2021
Lockado Repositionable Hemostasis Clip
PKL
Hemostatic Metal Clip For The Gi Tract
150d
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