Cleared Traditional

K182255 - CanGaroo Neuro Envelope (small)

Also marketed or referenced as:
CanGaroo Neuro Envelope (medium) CanGaroo Neuro Envelope (large) CanGaroo Neuro Envelope (extra large)

K182255 is an FDA 510(k) clearance for CanGaroo Neuro Envelope (small), manufactured by Aziyo Biologics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K182255 · Aziyo Biologics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
87d
Days
Class 2
Risk

K182255 is an FDA 510(k) clearance for the CanGaroo Neuro Envelope (small). 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 November 15, 2018 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aziyo Biologics, Inc. devices

FDA 510(k) Submission Details - K182255

510(k) Number K182255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2018
Decision Date November 15, 2018
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

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 125
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K182255.
Endoform Restella
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Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
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Colorado Therapeutics Xenograft Implant
K172937 · Colorado Therapeutics, LLC · Oct 2017
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
K173242 · Aziyo Biologics, Inc. · Oct 2017