HyperSuture White/Green Extension Line
K-Number: K242201 · 2025-03-27
ApplicantThreadstone, LLC
Decision Date2025-03-27
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HyperSuture White/Green Extension Line is a medical device manufactured by Threadstone, LLC. It received FDA 510(k) clearance on 2025-03-27 under approval number K242201. 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 HyperSuture White/Green Extension Line?
HyperSuture White/Green Extension Line is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Threadstone, LLC. The 510(k) number is K242201.
When was HyperSuture White/Green Extension Line approved by the FDA?
HyperSuture White/Green Extension Line received FDA 510(k) clearance on 2025-03-27, under approval number K242201.
What company makes HyperSuture White/Green Extension Line?
HyperSuture White/Green Extension Line is manufactured by Threadstone, LLC.
What is the FDA product code for HyperSuture White/Green Extension Line?
The FDA product code for HyperSuture White/Green Extension Line 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.