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
Mar 06, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
ODC
Endoscope Channel Accessory
30d
Cleared
Mar 06, 2024
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
ODC
Endoscope Channel Accessory
244d
Cleared
Mar 06, 2024
Choledochoscope System
FBN
Choledochoscope And Accessories, Flexible/rigid
287d
Cleared
Feb 26, 2024
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
171d
Cleared
Feb 26, 2024
GOLFF Sterile Anti-Fog Solution
OCT
Anti Fog Solution And Accessories, Endoscopy
250d
Cleared
Feb 23, 2024
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
108d
Cleared
Feb 16, 2024
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
FDF
Colonoscope And Accessories, Flexible/rigid
221d
Cleared
Feb 15, 2024
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
FGE
Stents, Drains And Dilators For The Biliary Ducts
202d
Cleared
Feb 09, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
ODC
Endoscope Channel Accessory
28d
Cleared
Feb 08, 2024
Endolumik Gastric Calibration Tube M Series (EGCT36M)
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
Feb 07, 2024
Purema® H Hemoconcentrator (EtO Sterilized)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
201d
Cleared
Feb 02, 2024
CVAC Aspiration System + CVAC Image Processor
FED
Endoscopic Access Overtube, Gastroenterology-urology
100d
Cleared
Feb 02, 2024
5008X Hemodialysis System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
248d
Cleared
Jan 26, 2024
ViSiGi 3D Gastric Sizing Tube
KNT
Tubes, Gastrointestinal (and Accessories)
28d
Cleared
Jan 26, 2024
Disposable Hemostatic Clips
PKL
Hemostatic Metal Clip For The Gi Tract
165d
Cleared
Jan 25, 2024
GentleCath Air for Women (CH10)
EZD
Catheter, Straight
147d
Cleared
Jan 23, 2024
2-Way 100% Silicone Cleartract Catheter
EZL
Catheter, Retention Type, Balloon
123d
Cleared
Jan 22, 2024
Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
PIO
Enteral Specific Transition Connectors
263d
Cleared
Jan 19, 2024
EndoSign® Cell collection device (ES-CYT-102)
EOX
Esophagoscope (flexible Or Rigid)
114d
Cleared
Jan 19, 2024
Plenity
QFQ
Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss
367d
Cleared
Jan 18, 2024
NxStage PureFlow Solution
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
112d
Cleared
Jan 18, 2024
ENFit Adaptor
PIO
Enteral Specific Transition Connectors
112d
Cleared
Jan 18, 2024
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
268d
Cleared
Jan 17, 2024
Video Ureteroscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
271d
Cleared
Jan 16, 2024
Hilzo Esophageal Stents
ESW
Prosthesis, Esophageal
449d
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