FDA.reportPublic FDA data

510(k) K943776

Device
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
510(k) number
K943776
Product code
HIN  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-03
Date received
1994-08-02
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
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L CASARSA
Address
353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061

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
K911699STI TISSUE MANIPULATORSurgical Technologies, Inc.1991-06-13
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases