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510(k) K980804

Device
SABRE BT BLUNT0TIP SURGICAL TROCAR
Applicant
ENDOSCOPIC CONCEPTS, INC.
510(k) number
K980804
Product code
FBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-01
Date received
1998-03-02
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAMELA PAPINEAU
Address
50 Brewster St. Pawtucket RI US 02860 02860

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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

Legacy Summary#

summary

FDA Review#

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