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This device is used to grasp, crush and cut the penile foreskin on full term, newborn (up to 10 days) male infants.

AccuCirc Circumcision clamp/cutter

The provided text is an FDA 510(k) clearance letter for the AccuCirc Circumcision clamp/cutter. This document does not contain information regarding detailed acceptance criteria, study methodologies, or performance data for the device. Therefore, I cannot generate the requested table and study description based solely on the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a study demonstrating it met specific, quantitative performance acceptance criteria.

To answer your questions, I would need access to the actual 510(k) submission document (K061539) which would contain the performance testing data and acceptance criteria if such tests were conducted and submitted.

Therefore, I cannot provide the requested information from the given text.

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