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FDA 510(k)

TroClose1200

K-Number: K160564 · 2016-11-17

ApplicantGordian Surgical, Ltd.
Decision Date2016-11-17
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TroClose1200 is a medical device manufactured by Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2016-11-17 under approval number K160564. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TroClose1200?

TroClose1200 is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Gordian Surgical, Ltd.. The 510(k) number is K160564.

When was TroClose1200 approved by the FDA?

TroClose1200 received FDA 510(k) clearance on 2016-11-17, under approval number K160564.

What company makes TroClose1200?

TroClose1200 is manufactured by Gordian Surgical, Ltd..

What is the FDA product code for TroClose1200?

The FDA product code for TroClose1200 is GAM.

Other Devices by Gordian Surgical, Ltd.

K171494TroClose1200, TroClose1200 Cannula K253620TroClose 1200

Related Devices (Code: GAM)

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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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