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510(k) Data Aggregation
K Number
K192346Device Name
scaffolene CL100 Bioresorbable Collagen Matrix
Manufacturer
Date Cleared
2020-02-28
(183 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**Freudenberg Technology Innovation SE **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients including:
Pressure ulcers Diabetic ulcers Ulcers caused by mixed vascular etiologies Venous ulcers Second degree burns Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention
Device Description
scaffolene® CL100 Bioresorbable Collagen Matrix is a collagen wound dressing provided sterile, which maintains a moist wound environment and supports exudate management. It can be cut to wound size, is a pliable absorbent dressing and can be adapted to irregular wound surfaces. scaffolene® CL100 Bioresorbable Collagen Matrix is resorbable and it can be left in place during secondary dressing changes.
scaffolene® CL100 Bioresorbable Collagen Matrix will typically resorb in about 1-3 days (shown in wound healing study in vivo), although this will be influenced by the patient's overall health. It is not necessary to remove the wound dressing.
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