Cleared Traditional

K192452 - Lyograft

K192452 is the FDA 510(k) clearance for Lyograft by B. Bruan Surgical, SA. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K192452 · B. Bruan Surgical, SA · General & Plastic Surgery device
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Sep 2020
Decision
360d
Days
Class 2
Risk

K192452 is an FDA 510(k) clearance for the Lyograft. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by B. Bruan Surgical, SA (Rubi, ES). The FDA issued a Cleared decision on September 3, 2020 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 B. Bruan Surgical, SA devices

Submission Details

510(k) Number K192452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date September 03, 2020
Days to Decision 360 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
245d slower than avg
Panel avg: 115d · This submission: 360d
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

Qreg Consulting, LLC
Robin M Fatzinger

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 44
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