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FDA 510(k)

PELNAC Meshed Bilayer Wound Matrix

K-Number: K213498 · 2022-07-14

ApplicantGunze Limited
Decision Date2022-07-14
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

PELNAC Meshed Bilayer 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 2022-07-14 under 510(k) number K213498. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELNAC Meshed Bilayer Wound Matrix?

PELNAC Meshed Bilayer Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Gunze Limited. The 510(k) number is K213498.

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

PELNAC Meshed Bilayer Wound Matrix received FDA 510(k) clearance on 2022-07-14, under 510(k) number K213498.

Who is the listed applicant for PELNAC Meshed Bilayer 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 Meshed Bilayer Wound Matrix?

The FDA product code for PELNAC Meshed Bilayer 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 ReinforcementK213573PELNAC Wound MatrixK191992PELNAC Bilayer Wound Matrix

Related Devices (Code: KGN)

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform 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

View on FDA Database →

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

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