LogoFDA 510(k) Search
K Number
K081782
Device Name
COLLIEVA
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2008-09-30

(99 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K061746
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Collieva™ may be used for the management of wounds such as:

  • · Pressure ulcers
  • Venous stasis ulcers
  • · Diabetic ulcers
  • · First and second degree burns
  • · Partial and full thickness wounds
  • · Superficial injuries
Device Description

Collieva™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the device Collieva™, a topical wound dressing. It declares substantial equivalence to a predicate device (CollaGuard™) and includes information on intended use and biocompatibility. However, it does not contain any information about a study with acceptance criteria or reported device performance data.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document focuses on regulatory submission for substantial equivalence rather than performance testing against specific criteria.

N/A