Cleared Traditional

K140383 - ALLOX2 TISSUE EXPANDERS

K140383 · Specialty Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
256d
Days
-
Risk

K140383 is an FDA 510(k) clearance for the ALLOX2 TISSUE EXPANDERS. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Specialty Surgical Products, Inc. (Victor, US). The FDA issued a Cleared decision on October 28, 2014 after a review of 256 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 Specialty Surgical Products, Inc. devices

FDA 510(k) Submission Details - K140383

510(k) Number K140383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date October 28, 2014
Days to Decision 256 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 115d · This submission: 256d
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 25
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K140383.
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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
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996