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FDA 510(k)

TIGR SURGICAL MESH , MODEL WK-6

K-Number: K092224 · 2010-01-25

ApplicantNovus Scientific Pte, Ltd.
Decision Date2010-01-25
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIGR SURGICAL MESH , MODEL WK-6 is the device name listed in this FDA 510(k) record. The listed applicant is Novus Scientific Pte, Ltd.. It received FDA 510(k) clearance on 2010-01-25 under 510(k) number K092224. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIGR SURGICAL MESH , MODEL WK-6?

TIGR SURGICAL MESH , MODEL WK-6 is a medical device that received FDA 510(k) clearance on 2010-01-25. The listed applicant is Novus Scientific Pte, Ltd.. The 510(k) number is K092224.

When did TIGR SURGICAL MESH , MODEL WK-6 receive FDA 510(k) clearance?

TIGR SURGICAL MESH , MODEL WK-6 received FDA 510(k) clearance on 2010-01-25, under 510(k) number K092224.

Who is the listed applicant for TIGR SURGICAL MESH , MODEL WK-6?

The FDA 510(k) record lists Novus Scientific Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIGR SURGICAL MESH , MODEL WK-6?

The FDA product code for TIGR SURGICAL MESH , MODEL WK-6 is FTL.

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Related Devices (Code: FTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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.

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