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Tigr Surgical Mesh, Model Wk-6

by Novus Scientific Pte, Ltd. 510(k)

Active United States

510(k) K092224

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092224 Date25 Jan 2010ClearedStatusActive

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  • Withdrawn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-2603-2016 FDA Class II initiated 19 Jul 2016

    Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

Specification

510(k)

510(k) Number
FDA Product Code
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent