Cleared Special

K243181 - Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (FDA 510(k) Clearance)

K243181 · Bionova Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
31d
Days
-
Risk

K243181 is an FDA 510(k) clearance for the Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on October 31, 2024 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bionova Medical, Inc. devices

Submission Details

510(k) Number K243181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date October 31, 2024
Days to Decision 31 days
Submission Type Special
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
83d faster than avg
Panel avg: 114d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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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