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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8377 Gastroenterology & Urology devices
Cleared
Mar 02, 2017
Vesair Cystoscopic Sheath
KNY
Accessories, Catheter, G-u
191d
Cleared
Mar 02, 2017
EndoPur Filter
FIP
Subsystem, Water Purification
296d
Cleared
Mar 02, 2017
Edi Catheter ENFit
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
435d
Cleared
Feb 28, 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
KNW
Instrument, Biopsy
56d
Cleared
Feb 24, 2017
Rusch Simplastic Foley Catheters
EZL
Catheter, Retention Type, Balloon
120d
Cleared
Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
89d
Cleared
Feb 15, 2017
Medela Low Dose Enteral Syringe
PNR
Enteral Syringes With Enteral Specific Connectors
229d
Cleared
Feb 09, 2017
Low Profile Balloon Feeding Device
KNT
Tubes, Gastrointestinal (and Accessories)
262d
Cleared
Feb 08, 2017
FB-U Hemodialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
357d
Cleared
Feb 07, 2017
Zilver 518TM Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
85d
Cleared
Jan 30, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
90d
Cleared
Jan 27, 2017
Universa Firm Ureteral Stents and Stent Sets
FAD
Stent, Ureteral
270d
Cleared
Jan 26, 2017
Onli Intermittent Catheter
GBM
Catheter, Urethral
73d
Cleared
Jan 25, 2017
Reliant Multistage Dilatation Balloon Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
170d
Cleared
Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
78d
Cleared
Jan 11, 2017
Desara TV, Desara Blue TV
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
159d
Cleared
Jan 11, 2017
ENDOCAM Flex HD Camera System 5521
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
258d
Cleared
Jan 06, 2017
Oracle EUS Balloon
FDF
Colonoscope And Accessories, Flexible/rigid
24d
Cleared
Jan 06, 2017
PrismaSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
81d
Cleared
Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
MPB
Catheter, Hemodialysis, Non-implanted
219d
Cleared
Jan 06, 2017
SureClip(TM) Repositionable Hemostasis Clip
PKL
Hemostatic Metal Clip For The Gi Tract
225d
Cleared
Jan 04, 2017
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
FEQ
Pump, Air, Non-manual, For Endoscope
29d
Cleared
Dec 23, 2016
Zilver 635 Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
53d
Cleared
Dec 22, 2016
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
FAD
Stent, Ureteral
50d
Cleared
Dec 22, 2016
HydraGuard 10 UltraFilter
NHV
System, Water Purification, General Medical Use
209d
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