Cleared Traditional

PELNAC Meshed Bilayer Wound Matrix (K213498) - FDA 510(k) Clearance

K213498 · Gunze Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
255d
Days
-
Risk

K213498 is an FDA 510(k) clearance for the PELNAC Meshed Bilayer Wound Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Gunze Limited (Ayabe, Kyoto, JP). The FDA issued a Cleared decision on July 14, 2022 after a review of 255 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 Gunze Limited devices

Submission Details

510(k) Number K213498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2021
Decision Date July 14, 2022
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Consultant

Emergo Global Consulting, LLC
Stuart R Goldman

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.

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K213498.
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K220317 · Organogenesis, Inc. · Jul 2022
Kerecis Silicone
K213231 · Kerecis Limited · Jun 2022
Fibrillar Collagen Wound Dressing
K213341 · Collagen Matrix, Inc. · May 2022