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
2287 Gastroenterology & Urology devices
Cleared
Oct 29, 2020
Flexible Video Cysto-Urethroscope (C-view)
FAJ
Cystoscope And Accessories, Flexible/rigid
29d
Cleared
Oct 29, 2020
Nutriglide(TM) Nasal Feeding Tube
KNT
Tubes, Gastrointestinal (and Accessories)
57d
Cleared
Oct 29, 2020
Nelson Sentinel Series Basic Chlorine Sentinel
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
349d
Cleared
Oct 26, 2020
G-EYE System
FDF
Colonoscope And Accessories, Flexible/rigid
60d
Cleared
Oct 21, 2020
PleurX Peritoneal Catheter System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
174d
Cleared
Oct 19, 2020
Single Use Rotatable and Repositionable Hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
112d
Cleared
Oct 15, 2020
Foley Catheter with Temperature Sensor
EYC
Catheter, Upper Urinary Tract
205d
Cleared
Oct 09, 2020
Medline ENfit OTC Feeding Syringe
PNR
Enteral Syringes With Enteral Specific Connectors
58d
Cleared
Oct 09, 2020
BIOTEQ Drainage Catheter Set (One Step Type)
FGE
Stents, Drains And Dilators For The Biliary Ducts
266d
Cleared
Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
FDI
Snare, Flexible
41d
Cleared
Oct 08, 2020
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
293d
Cleared
Oct 05, 2020
ClearEndoclip
PKL
Hemostatic Metal Clip For The Gi Tract
251d
Cleared
Oct 02, 2020
SOZO Body Fluid Analyzer
DSB
Plethysmograph, Impedance
298d
Cleared
Oct 01, 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
43d
Cleared
Sep 30, 2020
Wiygul Catheter
EZD
Catheter, Straight
26d
Cleared
Sep 30, 2020
EverLift Submucosal Lifting Agent
PLL
Submucosal Injection Agent
41d
Cleared
Sep 28, 2020
Enteral Feeding Syringes with ENfit connector (Model: 10 ml
PNR
Enteral Syringes With Enteral Specific Connectors
209d
Cleared
Sep 24, 2020
EndoGI S-Path Biliary Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Sep 21, 2020
Optiflux F180NR Dialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
360d
Cleared
Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
KOC
Accessories, Blood Circuit, Hemodialysis
136d
Cleared
Sep 17, 2020
GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
87d
Cleared
Sep 16, 2020
Tulsa-Pro System
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
35d
Cleared
Sep 12, 2020
Disposable Enteral Feeding Syringe with Enfit Connector
PNR
Enteral Syringes With Enteral Specific Connectors
257d
Cleared
Sep 11, 2020
AMICUS Separator System
GKT
Separator, Automated, Blood Cell, Diagnostic
193d
Cleared
Sep 03, 2020
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
MSD
Catheter, Hemodialysis, Implanted
30d
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