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510(k) Data Aggregation
K Number
K210949Device Name
Foundation Dermal Regeneration Scaffold (DRS) Solo
Manufacturer
Date Cleared
2022-08-11
(499 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Bionova Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Foundation DRS Solo is indicated for the management of wounds including:
- · Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Diabetic ulcers
- · First degree burns
- · Partial thickness burns (superficial second-degree burns)
- · Donor sites and other bleeding surface wounds
- · Abrasions
- · Trauma wounds (abrations, lacerations, skin tears)
- · Dehisced wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Foundation DRS Solo may be cut to size.
Device Description
Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.
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