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
8388 Gastroenterology & Urology devices
Cleared
Jan 07, 2014
ENDOSCOPIC SUTURE CUTTER
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
29d
Cleared
Jan 06, 2014
OPTIFLUX ULTRA DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
445d
Cleared
Jan 06, 2014
INTONEMV
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
20d
Cleared
Jan 03, 2014
PRISMAFLEX SYSTEM 7.10
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
220d
Cleared
Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
67d
Cleared
Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
FBO
Cystourethroscope
234d
Cleared
Jan 02, 2014
GELPOINT PATH TRANSANAL ACCESS PLATFORM
FER
Anoscope And Accessories
58d
Cleared
Dec 31, 2013
REPROCESSED DILATING TIP TROCARS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
131d
Cleared
Dec 27, 2013
NXSTAGE 1.6M2 DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
256d
Cleared
Dec 23, 2013
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
EZD
Catheter, Straight
136d
Cleared
Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
176d
Cleared
Dec 20, 2013
IMAGE1 SPIES
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
176d
Cleared
Dec 20, 2013
SEAL BIOPSY VALVE - REUSABLE
OCX
Endoscopic Irrigation/suction System
106d
Cleared
Dec 20, 2013
NEOTRACT UROLIFT SYSTEM
PEW
Implantable Transprostatic Tissue Retractor System
56d
Cleared
Dec 20, 2013
MULTI-STAGE SNARE
FDI
Snare, Flexible
38d
Cleared
Dec 19, 2013
PHYSOFT AMS
MQS
System, Hemodialysis, Access Recirculation Monitoring
289d
Cleared
Dec 19, 2013
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
287d
Cleared
Dec 19, 2013
ELISIO-H HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
219d
Not Cleared
Dec 18, 2013
AXIOS STENT AND DELIVERY SYSTEM
PCU
Pancreatic Stent, Covered, Metallic, Removable
302d
Cleared
Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
FEQ
Pump, Air, Non-manual, For Endoscope
144d
Cleared
Dec 16, 2013
CLEARGUARD HD END CAP
PEH
Hemodialysis Catheter Luer End Cap
244d
Cleared
Dec 11, 2013
THD N-ANO ANOSCOPE
FER
Anoscope And Accessories
9d
Cleared
Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
338d
Cleared
Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
123d
Cleared
Dec 05, 2013
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
219d
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