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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2020-03-30 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K192490.

When did Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch receive FDA 510(k) clearance?

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

Who is the listed applicant for Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

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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