ACMI Bipolar Hemostatic Electrode

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K803214 ↗

FDA Product Code

FEH

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Acmi Rigi-Flex Nephorscope

  Class II

  FDA 510(k) K791182 Active Cleared 30 Jul 1979

• Colonoscope, 2-CHANNEL Log (ACMI TX-92)

  Class II

  FDA 510(k) K760452 Active Cleared 30 Aug 1976

• Duodenoscope, Molel Tx-6

  Class I

  FDA 510(k) K770754 Active Cleared 28 Apr 1977

• Acmi Aspirator Kit #8808

  Class II

  FDA 510(k) K811218 Active Cleared 1 Jul 1981

• Model Tx-8 Panendoscope

  Class II

  FDA 510(k) K760822 Active Cleared 21 Oct 1976

• Sterile Fluid Producing Unit #EP550

  Class II

  FDA 510(k) K832040 Active Cleared 29 Sep 1983

See all devices from American Cystocope Makers, Inc. →

• What types of surgical procedures is the ACMI Bipolar Hemostatic Electrode primarily used for, and why is its flexible design important in those settings?

  The ACMI Bipolar Hemostatic Electrode is primarily designed for use in gastroenterology and urology procedures, where precise hemostasis (stopping bleeding) is critical. Its flexible design allows for better maneuverability around curved or confined anatomical areas, such as within the gastrointestinal tract or urinary system, ensuring effective tissue contact and sealing of small blood vessels or bleeding sites during coagulation.

• Is the ACMI Bipolar Hemostatic Electrode intended for single-use or reusable applications, and what sterilization steps are required before each use?

  The ACMI Bipolar Hemostatic Electrode is reusable and must undergo proper sterilization before each use to maintain safety and efficacy. Since it is classified as a reusable medical instrument, it should be cleaned and sterilized according to the manufacturer’s guidelines, typically using methods like autoclaving or chemical sterilization, to prevent cross-contamination and ensure reliable performance in controlled clinical settings like operating rooms or endoscopic suites.

• How do I verify the regulatory clearance status of this device, and what does the ‘Substantially Equivalent’ (SESE) designation mean in this context?

  The ACMI Bipolar Hemostatic Electrode holds FDA 510(k) clearance (K803214) under the Traditional pathway, with a Substantially Equivalent (SESE) designation issued on January 15, 1981. This means the FDA determined that the device is not significantly different from a legally marketed predicate device in terms of technology, performance, and intended use, confirming its safety and effectiveness for bipolar electrocoagulation in gastroenterology and urology. You can verify this status via the FDA’s openFDA database using the device’s K-number (K803214) or registration number.

• What storage conditions should be followed for the ACMI Bipolar Hemostatic Electrode to ensure its longevity and functionality?

  While the device data does not specify exact storage conditions, as a reusable medical instrument, the ACMI Bipolar Hemostatic Electrode should be stored in a clean, dry, and protected environment to prevent damage or contamination. After sterilization, it should be kept in a designated instrument tray or packaging until use, following the manufacturer’s maintenance guidelines to preserve its structural integrity and electrical functionality for repeated clinical applications.