HYALOMATRIX PA— 510(k) K073251

Clearance details

Applicant

Fidia Advanced Biopolymers Srl

Product code

Code QSZ

Device class

Unclassified

Advisory panel

Unknown

Date received

2007-11-19

Decision date

2007-12-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, US

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• Z-2423-2018 — Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.Class II·Terminated·Anika Therapeutics, Inc.·20180510

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073251.