Cleared Traditional

K070303 - SILICONE TISSUE EXPANDER

K070303 · Specialty Surgical Products · General & Plastic Surgery device
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Jun 2007
Decision
142d
Days
-
Risk

K070303 is an FDA 510(k) clearance for the SILICONE TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Specialty Surgical Products (Victor, US). The FDA issued a Cleared decision on June 22, 2007 after a review of 142 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K070303

510(k) Number K070303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2007
Decision Date June 22, 2007
Days to Decision 142 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
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 52
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K070303.
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813 · Mentor Corp. · Apr 2013
LIFECELL TISSUE EXPANDER
K112534 · Lifecell Corp. · Aug 2012
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
K102806 · Allergan Medical · Jan 2011
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K983385 · Hutchison Intl., Inc. · Mar 1999
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
K983792 · Seare Biomedical Corp. · Dec 1998
K070303 · SILICONE TISSUE EXPANDER
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