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510(k) K944640

Device
LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
Applicant
GABRIS SURGICAL CORP.
510(k) number
K944640
Product code
FBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-11
Date received
1994-09-21
Regulation
876.5090
Classification name
Trocar, Gastro-urology
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KENNETH A BELTRAN
Address
1432 N. Great Neck Rd., Suite 204 Virginia Beach VA US 23454 23454

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FBQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012198GIBBONS STERILE TROCAR KITSGibbons Surgical Corp.2001-08-09
K980804SABRE BT BLUNT0TIP SURGICAL TROCAREndoscopic Concepts, Inc.1998-04-01
K944104GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.1994-09-13
K942885AUTO SUTURE MODIFIED GRIPUnited States Surgical, A Division of Tyco Healthc1994-08-22
K934724AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.1993-12-23
K904638TROCAR DISPOSABLEL.A.S.E.R., Inc.1991-02-21
K900123AUTO SUTURE SURGIPORT SPIRAL SLEEVEUnited States Surgical, A Division of Tyco Healthc1990-04-04
K841716ENDOPORT EROCAREndotherapeutics1984-06-28

Legacy Summary#

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FDA Review#

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