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FDA 510(k)

TroClose1200, TroClose1200 Cannula

K-Number: K171494 · 2017-06-15

ApplicantGordian Surgical, Ltd.
Decision Date2017-06-15
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TroClose1200, TroClose1200 Cannula is a medical device manufactured by Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2017-06-15 under approval number K171494. 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 Cannula?

TroClose1200, TroClose1200 Cannula is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Gordian Surgical, Ltd.. The 510(k) number is K171494.

When was TroClose1200, TroClose1200 Cannula approved by the FDA?

TroClose1200, TroClose1200 Cannula received FDA 510(k) clearance on 2017-06-15, under approval number K171494.

What company makes TroClose1200, TroClose1200 Cannula?

TroClose1200, TroClose1200 Cannula is manufactured by Gordian Surgical, Ltd..

What is the FDA product code for TroClose1200, TroClose1200 Cannula?

The FDA product code for TroClose1200, TroClose1200 Cannula is GAM.

Other Devices by Gordian Surgical, Ltd.

K160564TroClose1200 K253620TroClose 1200

Related Devices (Code: GAM)

K160564TroClose1200Gordian Surgical, Ltd. K161726E-Pack Procedure KitETHICON, Inc. K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing DeviceEthicon, LLC K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. K171001Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical SutureCpt Sutures Co., 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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