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FDA 510(k)

Endoform Dermal Template

K-Number: K260669 · 2026-06-24

Decision Date2026-06-24
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Endoform Dermal Template is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K260669. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoform Dermal Template?

Endoform Dermal Template is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K260669.

When did Endoform Dermal Template receive FDA 510(k) clearance?

Endoform Dermal Template received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260669.

Who is the listed applicant for Endoform Dermal Template?

The FDA 510(k) record lists Aroa Biosurgery , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoform Dermal Template?

The FDA product code for Endoform Dermal Template is KGN.

Related Clinical Trials

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.

Other records listing Aroa Biosurgery , Ltd. 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.

View all 10 devices →

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.

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.