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FDA 510(k)

Bonvadis Topical Cream

K-Number: K212554 · 2022-08-19

ApplicantStemcyte, Inc.
Decision Date2022-08-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Bonvadis Topical Cream is a medical device manufactured by Stemcyte, Inc.. It received FDA 510(k) clearance on 2022-08-19 under approval number K212554. 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 Bonvadis Topical Cream?

Bonvadis Topical Cream is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Stemcyte, Inc.. The 510(k) number is K212554.

When was Bonvadis Topical Cream approved by the FDA?

Bonvadis Topical Cream received FDA 510(k) clearance on 2022-08-19, under approval number K212554.

What company makes Bonvadis Topical Cream?

Bonvadis Topical Cream is manufactured by Stemcyte, Inc..

What is the FDA product code for Bonvadis Topical Cream?

The FDA product code for Bonvadis Topical Cream is FRO. This falls under the Anesthesiology category.

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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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