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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K760452 ↗

FDA Product Code

FDF

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Acmi Rigi-Flex Nephorscope

  Class II

  FDA 510(k) K791182 Active Cleared 30 Jul 1979

• ACMI Bipolar Hemostatic Electrode

  Class II

  FDA 510(k) K803214 Active Cleared 15 Jan 1981

• 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 is the ACMI TX-92 2-Channel Colonoscope used for?

  The ACMI TX-92 2-Channel Colonoscope is designed for visual examination of the colon, enabling diagnostic and therapeutic procedures such as biopsies, polyp removal, or relief of obstructions. Its dual-channel configuration allows simultaneous insertion of instruments or irrigation while maintaining visualization, improving procedural efficiency and flexibility.

• Is the ACMI TX-92 2-Channel Colonoscope reusable or single-use?

  The ACMI TX-92 2-Channel Colonoscope is a reusable medical device. After each use, it must undergo thorough cleaning, disinfection, and sterilization to ensure safety and functionality for subsequent procedures. Proper maintenance is critical to prevent cross-contamination and preserve device integrity.

• What are the storage requirements for the ACMI TX-92 2-Channel Colonoscope?

  The device must be stored according to the manufacturer’s guidelines to maintain functionality and sterility. This typically includes keeping it in a clean, dry environment, protected from physical damage, and following any specific storage protocols provided by American Cystocope Makers, Inc. to ensure longevity and readiness for use.

• Does the ACMI TX-92 2-Channel Colonoscope have any special MRI safety considerations?

  The manufacturer does not provide specific MRI safety information for the ACMI TX-92 2-Channel Colonoscope. Clinicians should verify compatibility with MRI systems before use in such environments, as metallic components or other materials could pose risks during MRI procedures.

• What regulatory clearance does the ACMI TX-92 2-Channel Colonoscope hold?

  The ACMI TX-92 2-Channel Colonoscope holds FDA 510(k) clearance under the classification of Flexible Diagnostic Endoscope (FDF). This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness.