K905484 - ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT (FDA 510(k) Clearance)

K905484 is an FDA 510(k) clearance for the ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mentor Corp. devices