K884250 - RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) (FDA 510(k) Clearance)

K884250 is an FDA 510(k) clearance for the RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.). Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 244 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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