FCG

Product Code: FCG


Products Classified as FCG

1748Biopsy NeedleGastroenterology-urology Biopsy Instrument.

Total Product Life Cycle (TPLC) Devices

1748Biopsy NeedleGastroenterology-urology Biopsy Instrument.

FDA Consensus Standards

Biopsy Needle [29857]21 CFR §876.1075 🔎

Pre-market Notifications for FCG

K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation
K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation
K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland Ltd.
K181994Single Use Aspiration Needle NA-U201HOlympus Medical Systems Corp.
K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial NeedleAprioMed AB
K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.
K180449Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.
K180363Clear-Tip EUS-FNAFinemedix Co. Ltd.
K180037Beacon EUS Access SystemCovidien Llc
K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.
K171596ECHO-3-22: Echotip Ultra And EUSN-1, EUSN-3: Echotip Ultrasound NeedleWilson-Cook Medical Inc.
K160890Howell Biliary Introducer NeedleWILSON-COOK MEDICAL, INC.
K160423Perineologic Access NeedleCorbin Clinical Resources, LLC
K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland Ltd.
K160098Single Use Aspiration Needle NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.

Global Unique Device Identification Database

10801741085137Biopsy needle
10801741085120Biopsy needle
10801741085113Biopsy needle
10801741085106Biopsy needle
10801741085090Biopsy needle
10801741085083Biopsy needle
10801741085076Biopsy needle
10801741085069Biopsy needle
10801741085052Biopsy needle
10801741085045Biopsy needle
10801741085038Biopsy needle
10801741085021Biopsy needle
10801741085014Biopsy needle
10801741085007Biopsy needle
10801741084994Biopsy needle

Maude Adverse Events

ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-31
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-31
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-31
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-31
UNKNOWNUNKNOWN2020-03-27
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLECOOK IRELAND LTD2020-03-26
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLECOOK IRELAND LTD2020-03-26
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLECOOK IRELAND LTD2020-03-25
SINGLE USE ASPIRATION NEEDLE NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.2020-03-24
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-23
SINGLE USE ASPIRATION NEEDLE NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.2020-03-23
TEMNO NEEDLE BIOPSYMERIT MEDICAL SYSTEMS INC.2020-03-19
SINGLE USE ASPIRATION NEEDLEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-19
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-18
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-18
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-18
ECHOTIP ULTRA FIDUCIAL NEEDLECOOK ENDOSCOPY2020-03-13
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLECOOK IRELAND LTD2020-03-12
OLYMPUSOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
SINGLE USE ASPIRATION NEEDLEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLECOOK IRELAND LTD2020-03-10
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLECOOK IRELAND LTD2020-03-06
SINGLE USE ASPIRATION NEEDLE NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.2020-03-04
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLECOOK IRELAND LTD2020-03-04
ONCONTROL COAXIAL BIOPSY TRAY 11/13 GATELEFLEX MEDICAL2020-02-27
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-02-26
ONCONTROL PORTED ASPIRATION TRAY (BX/6)TELEFLEX MEDICAL2020-02-25
MAGNUM NEEDLEBARD PERIPHERAL VASCULAR, INC.2020-02-20
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLECOOK IRELAND LTD2020-02-19
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-02-18
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-02-18
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLECOOK IRELAND LTD2020-02-18
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-02-14
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-02-14
SHARKCORECOVIDIEN LP2020-02-11
TEMNO NEEDLE BIOPSYMERIT MEDICAL SYSTEMS INC.2020-02-06
SINGLE USE ASPIRATION NEEDLEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-03
UNKNOWNCOOK INC2020-01-31
UNKNOWNCOOK INC2020-01-31
UNKNOWNCOOK INC2020-01-31
UNKNOWNCOOK INC2020-01-30
UNKNOWNCOOK INC2020-01-30
SINGLE USE ASPIRATION NEEDLEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-24
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLECOOK IRELAND LTD2020-01-24
UNKNOWNUNKNOWN2020-01-21
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLECOOK IRELAND LTD2020-01-16
TEMNO EVOLUTIONMERIT MEDICAL SYSTEMS MEXICO2020-01-15
MAGNUM NEEDLEBARD PERIPHERAL VASCULAR, INC.2020-01-15
BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENTBARD PERIPHERAL VASCULAR, INC.2020-01-15
MAGNUM CORE BIOPSY NEEDLESBARD PERIPHERAL VASCULAR, INC.2020-01-15
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