Cleared Traditional

K143354 - Natrelle 133 Plus Tissue Expander

K143354 · Allergan, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
269d
Days
-
Risk

K143354 is an FDA 510(k) clearance for the Natrelle 133 Plus Tissue Expander. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on August 20, 2015 after a review of 269 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.

View all Allergan, Inc. devices

FDA 510(k) Submission Details - K143354

510(k) Number K143354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2014
Decision Date August 20, 2015
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 38
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CPX Control Breast Tissue Expander
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