510(k) K213498

PELNAC Meshed Bilayer Wound Matrix by Gunze Limited — Product Code KGN

K213498 is an FDA 510(k) premarket notification submitted by Gunze Limited for the device "PELNAC Meshed Bilayer Wound Matrix". The FDA issued a decision of Substantially Equivalent on July 14, 2022. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Gunze Limited has at least 4 other 510(k) clearances on record.