K833502 - RADOVAN SUBCUTANEOUS TISSUE EXPANDER (FDA 510(k) Clearance)

K833502 is an FDA 510(k) clearance for the RADOVAN SUBCUTANEOUS TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by American Heyer Schulte (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 121 days - within the typical 510(k) review window.

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.

View all American Heyer Schulte devices