Cleared Traditional

VersaWrap (K203600) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203600 · Alafair Biosciences, Inc. · General & Plastic Surgery device
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Mar 2021
Decision
90d
Days
Class 2
Risk

K203600 is an FDA 510(k) clearance for the VersaWrap. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on March 9, 2021 after a review of 90 days - within the typical 510(k) review window.

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: 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 Alafair Biosciences, Inc. devices

Submission Details

510(k) Number K203600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date March 09, 2021
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 Consultant

Namsa
Angela Mallery

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTM Mesh, Surgical

All 36
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K203600.
VersaWrap
K213163 · Alafair Biosciences, Inc. · Oct 2021
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
K213125 · Synovis Life Technologies. Inc. (A Subsidiary of Baxter · Oct 2021
Nexo-Gide Bilayer Collagen Membrane
K203496 · Geistlich Pharma AG · Jul 2021
Lyograft
K192452 · B. Bruan Surgical, SA · Sep 2020
Biodesign Staple Line Reinforcement
K201000 · Cook Biotech Incorporated · Jul 2020
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
K201313 · Aziyo Biologics, Inc. · Jun 2020