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FDA 510(k)

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch

K-Number: K192490 · 2020-03-30

ApplicantTeleflex Medical
Decision Date2020-03-30
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2020-03-30 under approval number K192490. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch?

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch is a medical device that received FDA 510(k) clearance on 2020-03-30. It is manufactured by Teleflex Medical. The 510(k) number is K192490.

When was Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch approved by the FDA?

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch received FDA 510(k) clearance on 2020-03-30, under approval number K192490.

What company makes Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch?

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch is manufactured by Teleflex Medical.

What is the FDA product code for Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch?

The FDA product code for Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch is GAT.

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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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