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510(k) K911699

Device
STI TISSUE MANIPULATOR
Applicant
SURGICAL TECHNOLOGIES, INC.
510(k) number
K911699
Product code
HIN  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-13
Date received
1991-04-16
Regulation
884.4150
Classification name
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALAN T BECKMAN
Address
750 Goddard Ave. Chesterfield MO US 63005 63005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142525PK Lap LoopOlympus Winter & Ibe GmbH2014-11-21
K130305LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical Aps2013-07-24
K122983KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.2013-06-26
K122605PKS BILLGyrus Acmi, Inc.2012-12-05
K113080TUBALGATORMectra Labs, Inc.2012-06-29
K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.2011-12-02
K111059GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.2011-09-01
K990147BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771Richard Wolf Medical Instruments Corp.1999-04-16
K971565BICOAG COAGULATING FORCEPSEverest Medical Corp.1998-03-12
K926517ELMED LBC 50-PElmed, Inc.1994-11-15
K943776COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIESRichard Wolf Medical Instruments Corp.1994-11-03
K871745MODEL 26021C BIPOLAR COAGULATORKARL STORZ Endoscopy-America, Inc.1987-07-10
K790043TRACOR, CANNULA, BICEPTS BIPOLARNeomed Corp.1979-02-08
K781109FORCEPS, ELECTROSURGICALKli1978-09-14
K781089ONE INCISION BI-POLAR ELECTRO. FORCEPSKli1978-07-17

Legacy Summary#

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FDA Review#

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