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FDA 510(k)

Bonvadis®

K-Number: K261638 · 2026-06-17

ApplicantOneness Biotech Co., Ltd.
Decision Date2026-06-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Bonvadis® is the device name listed in this FDA 510(k) record. The listed applicant is Oneness Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K261638. 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®?

Bonvadis® is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Oneness Biotech Co., Ltd.. The 510(k) number is K261638.

When did Bonvadis® receive FDA 510(k) clearance?

Bonvadis® received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261638.

Who is the listed applicant for Bonvadis®?

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

What is the FDA product code for Bonvadis®?

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

Other records listing Oneness Biotech Co., 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.

K251093Bonvadis®

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.

K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K254073StatSeal DiscMerit Medical Systems, Inc.K254191IWD-Gel™InnovaCorium, Inc.K252023MiraChlor Antimicrobial Wound SolutionLetus CorporationK251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH

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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