Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

K-Number: K191749 · 2020-03-26

ApplicantNovus Scientific AB
Decision Date2020-03-26
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is a medical device manufactured by Novus Scientific AB. It received FDA 510(k) clearance on 2020-03-26 under approval number K191749. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIGR Matrix Surgical Mesh, TIGR Surgical Mesh?

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Novus Scientific AB. The 510(k) number is K191749.

When was TIGR Matrix Surgical Mesh, TIGR Surgical Mesh approved by the FDA?

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh received FDA 510(k) clearance on 2020-03-26, under approval number K191749.

What company makes TIGR Matrix Surgical Mesh, TIGR Surgical Mesh?

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is manufactured by Novus Scientific AB.

What is the FDA product code for TIGR Matrix Surgical Mesh, TIGR Surgical Mesh?

The FDA product code for TIGR Matrix Surgical Mesh, TIGR Surgical Mesh is OWT.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery COMPLETED

Other Devices by Novus Scientific AB

K163005TIGR Matrix Surgical Mesh

Related Devices (Code: OWT)

K163005TIGR Matrix Surgical MeshNovus Scientific AB K173143Phasix ST MeshC.R. Bard, Inc. K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc. K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑