Rectal dilator, single-use

A rectal dilator, single-use is a sterile surgical instrument intended to gently expand the anal sphincter and canal when the opening is too narrow for normal function or to allow passage of diagnostic or therapeutic instruments. It is used clinically in procedures such as anorectal examinations, treatment of anal stenosis, or preparation for endoscopic interventions where mechanical dilation is required.

As a single-use device, it is supplied sterile and intended for one patient procedure only, then discarded. Regulatory oversight focuses on ensuring sterility, material safety, and performance for its intended dilation function, with classification and conformity assessment based on its invasive nature and duration of use, though specific regulatory class varies by jurisdiction.