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
612 Gastroenterology & Urology devices
Cleared
Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
QNP
Gastrointesinal Lesion Software Detection System
28d
Cleared
Jan 11, 2024
CoralView® Single-use Digital Flexible Ureteroscope (U10)
FGB
Ureteroscope And Accessories, Flexible/rigid
209d
Cleared
Jan 11, 2024
Disposable Hemoclip (AF series)
PKL
Hemostatic Metal Clip For The Gi Tract
220d
Cleared
Jan 05, 2024
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
99d
Cleared
Dec 18, 2023
AMT G-Tube Balloon Gastrostomy Feeding Device
KNT
Tubes, Gastrointestinal (and Accessories)
453d
Cleared
Dec 15, 2023
EW10-EC02 Endoscopy Support Program
QNP
Gastrointesinal Lesion Software Detection System
273d
Cleared
Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
FGB
Ureteroscope And Accessories, Flexible/rigid
28d
Cleared
Dec 06, 2023
2008T BlueStar Hemodialysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
230d
Cleared
Dec 01, 2023
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
65d
Cleared
Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
ODC
Endoscope Channel Accessory
126d
Cleared
Nov 28, 2023
Gold Probe Bipolar Electrohemostasis Catheter
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
90d
Cleared
Nov 21, 2023
Endoscopy Irrigation Tubing
OCX
Endoscopic Irrigation/suction System
245d
Cleared
Oct 27, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
28d
Cleared
Oct 26, 2023
Luja Coude (20108 Male CH18 - large packaging)
EZD
Catheter, Straight
30d
Cleared
Oct 23, 2023
Swiss LthoClast Trilogy
FEO
Lithotriptor, Ultrasonic
206d
Cleared
Oct 20, 2023
BioShield Biopsy Valve (00711124)
ODC
Endoscope Channel Accessory
29d
Cleared
Oct 20, 2023
Unicare (K-UNICARE-USA)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
197d
Cleared
Oct 17, 2023
SOZO Pro
DSB
Plethysmograph, Impedance
96d
Cleared
Oct 17, 2023
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
FBN
Choledochoscope And Accessories, Flexible/rigid
181d
Cleared
Oct 16, 2023
ANDORATE® Valve Kit
ODC
Endoscope Channel Accessory
91d
Cleared
Oct 05, 2023
MFG-05
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
197d
Cleared
Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
90d
Cleared
Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
PEW
Implantable Transprostatic Tissue Retractor System
30d
Cleared
Sep 18, 2023
Apollo ESG NXT System, Apollo REVISE NXT System
QTD
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
27d
Cleared
Sep 15, 2023
Over-tube (TR-1208A)
FED
Endoscopic Access Overtube, Gastroenterology-urology
182d
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