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510(k) K863595

Device
COATED SUTURE NEEDLE
Applicant
SHARPOINT, INC.
510(k) number
K863595
Product code
GAB  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-24
Date received
1986-09-15
Regulation
878.4800
Classification name
Needle, Suturing, Disposable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID A YATES
Address
2850 Windmill Rd. Reading PA US 19608 19608

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012199DIGICAPHumana USA, Inc.2001-12-19
K980988AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)Axya Medical, Inc.1998-05-11
K932591ENDO-JUDGESynergistic Medical Technologies, Inc.1993-12-22
K895681CONTRAST BACKGROUND MATERIALApplied Medical Technologies1989-10-24
K831648ANCHOR BRAND SURGICAL NEEDLESAnchor Products Co.1983-08-16
K812444RADIATION STERILIZATION FOR NEEDLE CNTRDevon Industries, Inc.1981-12-14
K801976SCANLAN STERNUM NEEDLE-SUTUREScanlan Intl., Inc.1980-09-26

Legacy Summary#

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FDA Review#

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