FDA.reportPublic FDA data

510(k) K920706

Device
MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
Applicant
RETRAX
510(k) number
K920706
Product code
FHQ  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-26
Date received
1992-02-18
Regulation
876.4730
Classification name
Holder, Needle, Gastroenterologic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DONALD KRANENDOBK
Address
800 W. Wausau Cir. Wausau WI US 54401 54401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FHQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974327WINGED NEEDLE HOLDERPhx Technologies Corp.1998-01-09
K924196LAPAROSCOPIC NEEDLE HOLDERNusurg, Inc.1993-06-25
K930330ENDOSCOPIC NEEDLEHOLDER, MODIFICATIONHolmed Corp.1993-06-08
K85177925-100,25-220 VARIOUS NEEDLE HOLDERSArtiberia1985-06-20
K85178025-230 TO 25-390 VARIOUS NEEDLE HOLDERSArtiberia1985-06-20
K771859NEEDLE HOLDER, MICROVASCULAREdward Weck, Inc.1977-10-04

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