Konig Bell Circumcision Clamp

The Konig Bell Circumcision Clamp is a reusable surgical instrument made from German-grade 304 stainless steel composed of a base plate, bell, hook arm, and thumb screw. It compresses the foreskin during circumcision procedures in male infants, children, and adults, with the latter use being to assist in HIV prevention. The device is supplied non-sterile in low-density polyethylene pouches and must be cleaned and steam-sterilized at the healthcare facility before use.

The proposed device has the same design features (base plate, arm, bell, screw) and same product code (HFX) as the predicate. Key differences include: the proposed device offers ten bell sizes (0.8–3.5 cm) versus the predicate's four sizes; the proposed device is made of stainless steel 304 while the predicate is chrome-plated brass; the proposed device is reusable while the predicate is single-use; and the proposed device uses pre-vacuum steam sterilization while the predicate's sterilization method could not be determined.

ISO 10993-1:2009 Biological Evaluation of Medical Devices (biocompatibility framework); ISO 10993-5 (cytotoxicity); ISO 10993-10 (sensitization and irritation); ISO 10993-11 (systemic toxicity); ASTM F1089-18 (corrosion boil test). FDA guidance on Use of International Standard ISO 10993-1 (September 2023) was also referenced.