Cleared Traditional

Bonvadis® (K232655) - FDA 510(k) Clearance

K232655 · Stemcyte, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
265d
Days
-
Risk

K232655 is an FDA 510(k) clearance for the Bonvadis®. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Stemcyte, Inc. (Baldwin Park, US). The FDA issued a Cleared decision on May 22, 2024 after a review of 265 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 Stemcyte, Inc. devices

Submission Details

510(k) Number K232655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2023
Decision Date May 22, 2024
Days to Decision 265 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 115d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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