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Hyalomatrix Pa

by Fidia Advanced Biopolymers Srl 510(k)

Active United States

510(k) K073251

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073251 Date14 Dec 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-2423-2018 FDA Class II initiated 10 May 2018 on shared 510(k) K073251

    Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
QSZ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Fidia Advanced Biopolymers Srl

  • Jaloskin

    Unclassified

  • Laserskin Dressing

    Unclassified

  • Hyalomatrix Co

    Class II