Acmi Bipolar Hemostatic Electrode

FDA 510(k) K803214 · American Cystocope Makers, Inc.

Substantially Equivalent

510(k) numberK803214

Submission

Device name
Acmi Bipolar Hemostatic Electrode
Applicant
American Cystocope Makers, Inc.
Mchenry, IL, US
Received
December 18, 1980
Decision date
January 15, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FEH – Electrode, Flexible Suction Coagulator
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FEH

510(k)DeviceApplicantDecision
K130489Electrode, Flexible Suction CoagulatorFEH · Special Optim, LLC04/19/2013SE
K122593Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide…FEH · Special Optim, LLC09/13/2012SE

More from Optim, LLC

510(k)DeviceDecision
K832040Sterile Fluid Producing Unit #EP550LJH · Traditional 09/29/1983SE
K812637Acmi Bipolar Hemostatic SourceGEI · Traditional 10/26/1981SE
K811218Acmi Aspirator Kit #8808EOQ · Traditional 07/01/1981SE
K791182Acmi Rigi-Flex NephorscopeFGA · Traditional 07/30/1979SE
K770754Duodenoscope, Molel TX-6FOG · Traditional 04/28/1977SE
K760822Model TX-8 PanendoscopeFAK · Traditional 10/21/1976SE
K760452Colonoscope, 2-CHANNEL Log (Acmi TX-92)FDF · Traditional 08/30/1976SE
K760451Air Water Source (Acmi Model 710)OCX · Traditional 08/30/1976SE

Questions and answers

When was Acmi Bipolar Hemostatic Electrode cleared by the FDA?

Acmi Bipolar Hemostatic Electrode (K803214) received a 510(k) decision of Substantially Equivalent on January 15, 1981, 28 days after the submission was received.

What is the product code of K803214?

The FDA product code is FEH – Electrode, Flexible Suction Coagulator, a Class II (moderate risk) device regulated under 21 CFR 876.4300.