Cleared Special

K130813 - MENTOR CPX 4 BREAST TISSUE EXPANDERS AN...

K130813 · Mentor Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
17d
Days
-
Risk

K130813 is an FDA 510(k) clearance for the MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST.... Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on April 11, 2013 after a review of 17 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 Corp. devices

Submission Details

510(k) Number K130813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2013
Decision Date April 11, 2013
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 20
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K130813.
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · Mentor Worldwide, LLC · Sep 2018
Natrelle 133S Tissue Expander
K182054 · Allergan · Aug 2018
Natrelle 133 Plus Tissue Expander
K143354 · Allergan, Inc. · Aug 2015
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991