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
5365 Gastroenterology & Urology devices
Cleared
May 24, 2018
EPX-4440FN Digital Video Processor with Light Source
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
98d
Cleared
May 24, 2018
Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
261d
Cleared
May 21, 2018
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
181d
Cleared
May 21, 2018
Polypectomy Snare
FDI
Snare, Flexible
252d
Cleared
May 18, 2018
Esophageal Stent System
ESW
Prosthesis, Esophageal
242d
Cleared
May 17, 2018
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
MSD
Catheter, Hemodialysis, Implanted
168d
Cleared
May 17, 2018
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FIE
Needle, Fistula
359d
Cleared
May 14, 2018
Disposable Biopsy Valve
OCX
Endoscopic Irrigation/suction System
154d
Cleared
May 10, 2018
2008T BlueStar Hemodialysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
132d
Cleared
May 08, 2018
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
FDS
Gastroscope And Accessories, Flexible/rigid
223d
Cleared
May 04, 2018
Caldera Medical Transobturator Helical Introducer, Left
PWJ
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
246d
Cleared
May 03, 2018
Repris Bladder Injection System
FBK
Endoscopic Injection Needle, Gastroenterology-urology
98d
Cleared
May 02, 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
EZN
Dilator, Catheter, Ureteral
119d
Cleared
May 01, 2018
Liberty Cycler Set
FKX
System, Peritoneal, Automatic Delivery
147d
Cleared
May 01, 2018
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
FGE
Stents, Drains And Dilators For The Biliary Ducts
215d
Cleared
Apr 26, 2018
Beacon EUS Access System
FCG
Biopsy Needle
111d
Cleared
Apr 19, 2018
Ultramatrix EUS Balloon
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
30d
Cleared
Apr 19, 2018
Embozene Color-Advanced Microspheres
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
93d
Cleared
Apr 19, 2018
Balloon Catheter and Balloon Ureteral Dilator Set
EZN
Dilator, Catheter, Ureteral
233d
Cleared
Apr 17, 2018
DiLumen C2
FDF
Colonoscope And Accessories, Flexible/rigid
180d
Cleared
Apr 17, 2018
Fusion OMNI Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
260d
Cleared
Apr 16, 2018
SOZO
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
90d
Cleared
Apr 16, 2018
Hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
217d
Cleared
Apr 16, 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
FAD
Stent, Ureteral
319d
Cleared
Apr 12, 2018
Padlock Clip defect closure device
PKL
Hemostatic Metal Clip For The Gi Tract
28d
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