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510(k) K191749

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh by Novus Scientific AB — Product Code OWT

K191749 is an FDA 510(k) premarket notification submitted by Novus Scientific AB for the device "TIGR Matrix Surgical Mesh, TIGR Surgical Mesh". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300. Novus Scientific AB has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
July 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during hernia repair.

Other clearances by Novus Scientific AB

  • K163005 — TIGR Matrix Surgical Mesh (July 27, 2017)

Other clearances for product code OWT

  • K243241 — Phasix ST Umbilical Hernia Patch (February 19, 2025)
  • K233661 — Transorb™ Self-Gripping Resorbable Mesh (February 13, 2024)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K190185 — Phasix ST Mesh with Open Positioning System (June 12, 2019)
  • K173143 — Phasix ST Mesh (April 25, 2018)
  • K163005 — TIGR Matrix Surgical Mesh (July 27, 2017)
  • K143380 — Phasix ST Mesh (June 5, 2015)
  • K120728 — PHASIX PLUG AND PATCH (October 22, 2012)
  • K101287 — TEPHAFLEX COMPOSITE MESH (August 30, 2010)
  • K033671 — GORE BIOABSORBABLE MESH (December 31, 2003)

FDA data resources