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510(k) K974327

Device
WINGED NEEDLE HOLDER
Applicant
PHX TECHNOLOGIES CORP.
510(k) number
K974327
Product code
FHQ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-09
Date received
1997-11-18
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
JAMES F CHAPEL, PH.D.
Address
1032 Shady Oaks Dr., # 100 Denton TX US 76205 76205

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
K924196LAPAROSCOPIC NEEDLE HOLDERNusurg, Inc.1993-06-25
K930330ENDOSCOPIC NEEDLEHOLDER, MODIFICATIONHolmed Corp.1993-06-08
K920706MAGNETIC POINT GUARD FOR SURGICAL NEEDLESRetrax1993-05-26
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#

summary

FDA Review#

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