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FDA 510(k)

Endoform Silver Dermal Template

K-Number: K172318 · 2017-11-17

ApplicantAroa Biosurgery
Decision Date2017-11-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Endoform Silver Dermal Template is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172318. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoform Silver Dermal Template?

Endoform Silver Dermal Template is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Aroa Biosurgery. The 510(k) number is K172318.

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

Endoform Silver Dermal Template received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172318.

Who is the listed applicant for Endoform Silver Dermal Template?

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

What is the FDA product code for Endoform Silver Dermal Template?

The FDA product code for Endoform Silver Dermal Template is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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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