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FDA 510(k)

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo

K-Number: K243181 · 2024-10-31

ApplicantBionova Medical, Inc.
Decision Date2024-10-31
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2024-10-31 under 510(k) number K243181. 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 Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K243181.

When did Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo receive FDA 510(k) clearance?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo received FDA 510(k) clearance on 2024-10-31, under 510(k) number K243181.

Who is the listed applicant for Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

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

What is the FDA product code for Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

The FDA product code for Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is FRO. This falls under the Anesthesiology category.

Other records listing Bionova Medical, 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.

K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoK231937Foundation Dermal Regeneration Scaffold (DRS) SoloK210949Foundation Dermal Regeneration Scaffold (DRS) Solo

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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