Cleared Traditional

K180826 - Natrelle 133 Plus MICROCELL Tissue Expa...

K180826 · Allergan · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2018
Decision
266d
Days
-
Risk

K180826 is an FDA 510(k) clearance for the Natrelle 133 Plus MICROCELL Tissue Expander. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 266 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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Submission Details

510(k) Number K180826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date December 21, 2018
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 18
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K180826.
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CPX 4 Breast Tissue Expander with Smooth Surface
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Natrelle 133S Tissue Expander
K182054 · Allergan · Aug 2018
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813 · Mentor Corp. · Apr 2013