HyperSuture All Blue Extension Line
K-Number: K241376 · 2024-08-09
ApplicantThreadstone, LLC
Decision Date2024-08-09
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HyperSuture All Blue Extension Line is a medical device manufactured by Threadstone, LLC. It received FDA 510(k) clearance on 2024-08-09 under approval number K241376. 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 All Blue Extension Line?
HyperSuture All Blue Extension Line is a medical device that received FDA 510(k) clearance on 2024-08-09. It is manufactured by Threadstone, LLC. The 510(k) number is K241376.
When was HyperSuture All Blue Extension Line approved by the FDA?
HyperSuture All Blue Extension Line received FDA 510(k) clearance on 2024-08-09, under approval number K241376.
What company makes HyperSuture All Blue Extension Line?
HyperSuture All Blue Extension Line is manufactured by Threadstone, LLC.
What is the FDA product code for HyperSuture All Blue Extension Line?
The FDA product code for HyperSuture All Blue 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.