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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 a medical device manufactured by Bionova Medical, Inc.. It received FDA 510(k) clearance on 2024-10-31 under approval 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. It is manufactured by Bionova Medical, Inc.. The 510(k) number is K243181.

When was Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo approved by the FDA?

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

What company makes Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is manufactured by Bionova Medical, Inc..

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.

Related Clinical Trials

NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING

Related PubMed Literature

PMID: 39933996 Micro/Nanobiomimetic Iron-Based Scaffold Induces Vascularized Bone Regeneration To Repair Large Segmental Bone Defect in Load-Bearing Sites. ACS nano (2025)

Other Devices by Bionova Medical, Inc.

K210949Foundation Dermal Regeneration Scaffold (DRS) Solo K231937Foundation Dermal Regeneration Scaffold (DRS) Solo K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

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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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