Cleared Special

K182054 - Natrelle 133S Tissue Expander

K182054 · Allergan · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
29d
Days
-
Risk

K182054 is an FDA 510(k) clearance for the Natrelle 133S Tissue Expander. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on August 29, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K182054

510(k) Number K182054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2018
Decision Date August 29, 2018
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 54
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K182054.
Sientra, inc. Portfinder
K221127 · Sientra, Inc. · May 2023
Natrelle 133 Plus MICROCELL Tissue Expander
K180826 · Allergan · Dec 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · Mentor Worldwide, LLC · Sep 2018
Unger Quad Injector
K161483 · Stradis Healthcare · Oct 2016
ARTOURA Breast Tissue Expanders with Smooth Surface
K161176 · Mentor Worldwide, LLC · May 2016
CPX 4 Breast Tissue Expander
K152496 · Mentor Worldwide, LLC · Feb 2016
K182054 · Natrelle 133S Tissue Expander
Download PDF FDA Summary Allergan