MR Associates Washing Tube/Measuring Tube

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

Full name

M.R. Assoc. Washing Tube/Measuring Tube

510(k) Number

K800962 ↗

FDA Product Code

ODC

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• M.R. Assoc. Ball Type Coagulator

  Class II

  FDA 510(k) K800964 Active Cleared 8 May 1980

• M.R. Assoc. Alligator Graspong Forceps

  Class II

  FDA 510(k) K800967 Active Cleared 8 May 1980

• M.R. Assoc. W Type Grasping Forceps

  Class II

  FDA 510(k) K800976 Active Cleared 8 May 1980

• M.R. Assoc. Rat Tooth Grasp Forceps

  Class II

  FDA 510(k) K800968 Active Cleared 8 May 1980

• M.R. Assoc. Power Cord

  Class II

  FDA 510(k) K800974 Active Cleared 8 May 1980

• Biopsy Forceps W/Needle M.R. Assoc.

  Class I

  FDA 510(k) K800963 Active Cleared 8 May 1980

See all devices from Mr Associates, Inc. →

• What specialties is this device primarily used in, and why is it relevant to those fields?

  The M.R. Associates Washing Tube/Measuring Tube is designed for use in gastroenterology and urology, as indicated by its advisory committee classification (GU) and medical specialty description. In these fields, it aids in irrigation and measurement during endoscopic procedures, ensuring proper cleaning of endoscope channels and accurate sizing of anatomical structures, which are critical for diagnostic and therapeutic interventions.

• Is this device single-use or reusable, and what does that mean for its maintenance?

  This device is reusable, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. Since it is not labeled as sterile or disposable, facilities must follow established protocols for reprocessing to ensure safety and functionality between uses, such as disinfection and sterilization as per facility guidelines.

• How is this device regulated, and what does the FDA clearance indicate about its safety and effectiveness?

  The device holds FDA 510(k) clearance under the classification ODC (Orthopedic Devices, Classification 2), though it is technically an Endoscope Channel Accessory. The clearance indicates that the FDA has determined it is substantially equivalent to a legally marketed device in terms of safety and effectiveness. This means it meets regulatory standards for its intended use in irrigation and measurement within endoscope channels.

• Are there different sizes or models available for this washing tube/measuring tube?

  While the provided data does not specify exact sizes or model variations, the registration numbers and FEI numbers suggest multiple listings, which may correspond to different lengths, diameters, or configurations. Clinicians should verify available options with the manufacturer or distributor to ensure compatibility with their endoscope systems and procedural needs.