Cleared Traditional

K192452 - Lyograft

K192452 is an FDA 510(k) clearance for Lyograft, manufactured by B. Bruan Surgical, SA. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K192452

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.

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 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.

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