Cleared Traditional

K240298 - Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (FDA 510(k) Clearance)

K240298 · Bionova Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
202d
Days
-
Risk

K240298 is an FDA 510(k) clearance for the Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on August 21, 2024 after a review of 202 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Bionova Medical, Inc. devices

Submission Details

510(k) Number K240298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date August 21, 2024
Days to Decision 202 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
88d slower than avg
Panel avg: 114d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

RQM+
Lucie Dalet

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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