K140383 - ALLOX2 TISSUE EXPANDERS (FDA 510(k) Clearance)

K140383 is an FDA 510(k) clearance for the ALLOX2 TISSUE EXPANDERS. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Specialty Surgical Products, Inc. (Victor, US). The FDA issued a Cleared decision on October 28, 2014 after a review of 256 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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