FDA 510(k)

PELNAC Wound Matrix

K-Number: K213573 · 2022-02-09

Decision Date2022-02-09

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

PELNAC Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gunze Limited. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K213573. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELNAC Wound Matrix?

PELNAC Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Gunze Limited. The 510(k) number is K213573.

When did PELNAC Wound Matrix receive FDA 510(k) clearance?

PELNAC Wound Matrix received FDA 510(k) clearance on 2022-02-09, under 510(k) number K213573.

Who is the listed applicant for PELNAC Wound Matrix?

The FDA 510(k) record lists Gunze Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PELNAC Wound Matrix?

The FDA product code for PELNAC Wound Matrix is KGN.

Other records listing Gunze Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221487NEOVEIL Staple Line Reinforcement K213498PELNAC Meshed Bilayer Wound Matrix K191992PELNAC Bilayer Wound Matrix

Related Devices (Code: KGN)

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.