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FDA 510(k)

T-Cuff

K-Number: K162365 · 2017-02-16

ApplicantTerumobct, Inc.
Decision Date2017-02-16
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

T-Cuff is a medical device manufactured by Terumobct, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K162365. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-Cuff?

T-Cuff is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Terumobct, Inc.. The 510(k) number is K162365.

When was T-Cuff approved by the FDA?

T-Cuff received FDA 510(k) clearance on 2017-02-16, under approval number K162365.

What company makes T-Cuff?

T-Cuff is manufactured by Terumobct, Inc..

What is the FDA product code for T-Cuff?

The FDA product code for T-Cuff is KCY.

Other Devices by Terumobct, Inc.

K153601Spectra Optia Apheresis System K181049Spectra Optia Apheresis System K172590Spectra Optia Apheresis System K183081Spectra Optia Apheresis System

Related Devices (Code: KCY)

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.

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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