Cleared Traditional

K161483 - Unger Quad Injector

K161483 · Stradis Healthcare · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
153d
Days
-
Risk

K161483 is an FDA 510(k) clearance for the Unger Quad Injector. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Stradis Healthcare (Lawrenceville, US). The FDA issued a Cleared decision on October 31, 2016 after a review of 153 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 Stradis Healthcare devices

FDA 510(k) Submission Details - K161483

510(k) Number K161483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2016
Decision Date October 31, 2016
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
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 K161483.
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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