FDA.report

510(k) K934724

Device
Aesculap Trocar Instrument Set
Applicant
AESCULAP, INC.
510(k) number
K934724
Product code
FBQ
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-23
Date received
1993-10-01
Regulation
876.5090
Classification name
Trocar, Gastro-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
VICTORIA MACKINNON
Address
1000 Gateway Blvd. South San Francisco CA US 94080 94080

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FBQ

510(k)DeviceApplicantDecision date
K012198GIBBONS STERILE TROCAR KITSGibbons Surgical Corp.2001-08-09
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
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