Cleared Traditional

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

K221127 · Sientra, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
387d
Days
-
Risk

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.

View all Sientra, Inc. devices

Submission Details

510(k) Number K221127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2022
Decision Date May 10, 2023
Days to Decision 387 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 115d · This submission: 387d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 9
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K221127.
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Motiva Flora SmoothSilk Tissue Expander
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AlloX2 Pro Tissue Expanders
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Natrelle 133 Plus MICROCELL Tissue Expander
K180826 · Allergan · Dec 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · Mentor Worldwide, LLC · Sep 2018
Natrelle 133S Tissue Expander
K182054 · Allergan · Aug 2018