Cleared Special

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (K173242) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173242 · Aziyo Biologics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
19d
Days
Class 2
Risk

K173242 is an FDA 510(k) clearance for the CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (lar.... Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Aziyo Biologics, Inc. (Roswell, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. 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 Aziyo Biologics, Inc. devices

Submission Details

510(k) Number K173242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2017
Decision Date October 25, 2017
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTM Mesh, Surgical

All 162
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K173242.
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