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
5372 Gastroenterology & Urology devices
Cleared
Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
FAD
Stent, Ureteral
26d
Cleared
Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
31d
Cleared
Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
224d
Cleared
Mar 04, 2003
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
90d
Cleared
Feb 27, 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
171d
Cleared
Feb 27, 2003
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
LJE
Catheter, Nephrostomy
80d
Cleared
Feb 24, 2003
MEDCOMP SC4
MSD
Catheter, Hemodialysis, Implanted
196d
Cleared
Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
113d
Cleared
Feb 20, 2003
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
PKL
Hemostatic Metal Clip For The Gi Tract
90d
Cleared
Feb 06, 2003
BIOARC SP SLING KIT
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
23d
Cleared
Jan 29, 2003
1-CCD ENDOCAM 5520 SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
90d
Cleared
Jan 27, 2003
SPEEDICATH
GBM
Catheter, Urethral
119d
Cleared
Jan 23, 2003
BARD ER URETERAL STENT WITH SUTURE
FAD
Stent, Ureteral
181d
Cleared
Jan 15, 2003
MODIFICATION TO TEMNO BIOPSY NEEDLES
FCG
Biopsy Needle
30d
Cleared
Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jan 02, 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
198d
Cleared
Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
363d
Cleared
Dec 18, 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
KNQ
Dilator, Esophageal
23d
Cleared
Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
412d
Cleared
Dec 11, 2002
NXSTAGE CARTRIDGE EXPRESS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
358d
Cleared
Dec 11, 2002
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
KNW
Instrument, Biopsy
16d
Cleared
Nov 19, 2002
MONARC SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
29d
Cleared
Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
186d
Cleared
Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
FKP
System, Dialysate Delivery, Single Patient
225d
Cleared
Oct 31, 2002
MEDCOMP REPAIR KIT, MODEL ASPCRPK
NFK
Kit, Repair, Catheter, Hemodialysis
90d
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