Cleared Traditional

PELNAC Bilayer Wound Matrix (K191992) - FDA 510(k) Clearance

K191992 · Gunze Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2020
Decision
279d
Days
-
Risk

K191992 is an FDA 510(k) clearance for the PELNAC 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 April 29, 2020 after a review of 279 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 K191992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2019
Decision Date April 29, 2020
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
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
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