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Silverstream and Dermasept

by Enzysurge, Ltd. 510(k)

Active United States

510(k) K093227

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093227 Date10 Dec 2009ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FRO
FDA applicant
Enzysurge , Ltd.
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Enzysurge, Ltd.

  • SilverStream Gel

    Unclassified

  • Dermastream

    Class I