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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 the device name listed in this FDA 510(k) record. The listed applicant is Stemcyte, Inc.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) 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. The listed applicant is Stemcyte, Inc.. The 510(k) number is K212554.

When did Bonvadis Topical Cream receive FDA 510(k) clearance?

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

Who is the listed applicant for Bonvadis Topical Cream?

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

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.

Other records listing Stemcyte, Inc. 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.

K232655Bonvadis®

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.

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