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510(k) K803214

Device
ACMI BIPOLAR HEMOSTATIC ELECTRODE
Applicant
AMERICAN CYSTOCOPE MAKERS, INC.
510(k) number
K803214
Product code
FEH  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-15
Date received
1980-12-18
Regulation
876.4300
Classification name
Electrode, Flexible Suction Coagulator
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130489ELECTRODE, FLEXIBLE SUCTION COAGULATOROptim, LLC2013-04-19
K122593PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2Optim, LLC2012-09-13

Legacy Summary#

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FDA Review#

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