TroClose 1200
K-Number: K253620 · 2025-12-16
ApplicantGordian Surgical, Ltd.
Decision Date2025-12-16
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TroClose 1200 is a medical device manufactured by Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2025-12-16 under approval number K253620. 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 TroClose 1200?
TroClose 1200 is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Gordian Surgical, Ltd.. The 510(k) number is K253620.
When was TroClose 1200 approved by the FDA?
TroClose 1200 received FDA 510(k) clearance on 2025-12-16, under approval number K253620.
What company makes TroClose 1200?
TroClose 1200 is manufactured by Gordian Surgical, Ltd..
What is the FDA product code for TroClose 1200?
The FDA product code for TroClose 1200 is 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.