Cleared Traditional

K220498 - NovoGen Wound Matrix (FDA 510(k) Clearance)

K220498 · Novabone Products, LLC · General & Plastic Surgery device

Jun 2023

Decision

472d

Days

—

Risk

K220498 is an FDA 510(k) clearance for the NovoGen Wound Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Novabone Products, LLC (Alachua, US). The FDA issued a Cleared decision on June 9, 2023, 472 days after receiving the submission on February 22, 2022.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K220498 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 2022
Decision Date	June 09, 2023
Days to Decision	472 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF