Cleared Special

K102806 - NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS

K102806 · Allergan Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
99d
Days
-
Risk

K102806 is an FDA 510(k) clearance for the NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan Medical (Goleta, US). The FDA issued a Cleared decision on January 5, 2011 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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FDA 510(k) Submission Details - K102806

510(k) Number K102806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date January 05, 2011
Days to Decision 99 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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 27
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K102806.
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
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · Specialty Surgical Products, Inc. · Feb 1998
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996