FDA.reportPublic FDA data

510(k) K920816

Device
PERCUGUIDE LESION MARKING
Applicant
E-Z-EM, INC.
510(k) number
K920816
Product code
GDF  
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-21
Date received
1992-02-06
Regulation
878.4800
Classification name
Guide, Needle, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARLENE WRIGHT
Address
P.O. Box 993 266 Queensbury Ave. Glens Falls NY US 12801 12801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.2003-07-23
K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.1995-05-26
K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco Healthc1995-03-15
K945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.1994-11-22
K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.1994-11-04
K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.1994-02-22
K935457LOCALIZATION WIRE OR MARKER - SURGICALBip USA, Inc.1994-02-17
K923840NEEDLE-GRABBERGuardian Angel Products, Inc.1993-07-13
K923835THE ELEVENTH FINGERGuardian Angel Products, Inc.1993-07-09
K925875HORIZONTAL NEEDLE GUIDE ATTACHMENTBip USA, Inc.1993-04-06
K924270BREAST LESION LOCALIZATION NEEDLECore Medical, Inc.1992-09-23
K923120MICROGUIDE LESION MARKING SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1992-09-01
K914941SIMON BREAST LESION LOCALIZATION NEEDLEManan Medical Products, Inc.1992-05-14
K904172ACCUPLACE (TM)Dlp, Inc.1990-11-21
K900903KOPANS HOOKWIRE LESION LOCALIZATION NEEDLEMilex Products, Inc.1990-05-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases