K221127 - Sientra, inc. Portfinder (FDA 510(k) Clearance)

K221127 is an FDA 510(k) clearance for the Sientra, inc. Portfinder. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Sientra, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on May 10, 2023 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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