K172140 - NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (FDA 510(k) Clearance)

K172140 is an FDA 510(k) clearance for the NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x .... Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on August 11, 2017 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Polynovo Biomaterials Pty, Ltd. devices