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 the FDA 510(k) clearance for CanGaroo Neuro Envelope (small) by Aziyo Biologics, Inc.. It is a Class 2 General & Plastic Surgery device (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

Submission Details

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.

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 44
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