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
5367 Gastroenterology & Urology devices
Cleared
Dec 01, 2010
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FFT
Electrode, Ph, Stomach
89d
Cleared
Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
KOD
Catheter, Urological
64d
Cleared
Oct 23, 2010
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
388d
Cleared
Oct 20, 2010
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
111d
Cleared
Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
425d
Cleared
Oct 18, 2010
RE-TRACE URETERAL ACCESS SHEATH
FED
Endoscopic Access Overtube, Gastroenterology-urology
49d
Cleared
Oct 08, 2010
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
78d
Cleared
Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
KGE
Forceps, Biopsy, Electric
116d
Cleared
Sep 30, 2010
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
154d
Cleared
Sep 13, 2010
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
74d
Cleared
Sep 07, 2010
MERIT BIPOLAR COAGULATION PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
27d
Cleared
Aug 27, 2010
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
57d
Cleared
Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Aug 05, 2010
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
87d
Cleared
Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
85d
Cleared
Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
73d
Cleared
Jul 19, 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jul 16, 2010
WATER BOTTLE CAP SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
84d
Cleared
Jul 14, 2010
OLYMPUS CF TYPE Y0023-L, Y0023I
FDF
Colonoscope And Accessories, Flexible/rigid
90d
Cleared
Jul 02, 2010
EVIS EXERAII 180 SYSTEM
NWB
Endoscope, Accessories, Narrow Band Spectrum
122d
Cleared
Jul 02, 2010
MEDLINE PVC URETHRAL CATHETER
EZD
Catheter, Straight
149d
Cleared
Jul 01, 2010
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
87d
Cleared
Jul 01, 2010
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
FAS
Electrode, Electrosurgical, Active, Urological
150d
Cleared
Jun 17, 2010
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
ESW
Prosthesis, Esophageal
206d
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