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510(k) K012198

Device
GIBBONS STERILE TROCAR KITS
Applicant
Gibbons Surgical Corp.
510(k) number
K012198
Product code
FBQ
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-09
Date received
2001-07-13
Regulation
876.5090
Classification name
Trocar, Gastro-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
LISA CRISSON
Address
1112 Jensen Dr., Suite 101 Virginia Beach VA US 23451 23451

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
K980804SABRE BT BLUNT0TIP SURGICAL TROCAREndoscopic Concepts, Inc.1998-04-01
K944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITGabris Surgical Corp.1994-10-11
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