Cleared Special

K182335 - CPX 4 Breast Tissue Expander with Smoot...

K182335 · Mentor Worldwide, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
28d
Days
-
Risk

K182335 is an FDA 510(k) clearance for the CPX 4 Breast Tissue Expander with Smooth Surface. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Worldwide, LLC (Irvin, US). The FDA issued a Cleared decision on September 25, 2018 after a review of 28 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.

View all Mentor Worldwide, LLC devices

FDA 510(k) Submission Details - K182335

510(k) Number K182335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2018
Decision Date September 25, 2018
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 24
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K182335.
AlloX2 Pro Tissue Expanders
K214124 · Sientra, Inc. · Jun 2023
Sientra, inc. Portfinder
K221127 · Sientra, Inc. · May 2023
Natrelle 133 Plus MICROCELL Tissue Expander
K180826 · Allergan · Dec 2018
Natrelle 133S Tissue Expander
K182054 · Allergan · Aug 2018
Natrelle 133 Plus Tissue Expander
K143354 · Allergan, Inc. · Aug 2015
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813 · Mentor Corp. · Apr 2013