Pitch PaSoft Tissue Reinforcement Device
K-Number: K230671 · 2023-05-31
ApplicantXiros, Ltd.
Decision Date2023-05-31
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Pitch PaSoft Tissue Reinforcement Device is a medical device manufactured by Xiros, Ltd.. It received FDA 510(k) clearance on 2023-05-31 under approval number K230671. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pitch PaSoft Tissue Reinforcement Device?
Pitch PaSoft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by Xiros, Ltd.. The 510(k) number is K230671.
When was Pitch PaSoft Tissue Reinforcement Device approved by the FDA?
Pitch PaSoft Tissue Reinforcement Device received FDA 510(k) clearance on 2023-05-31, under approval number K230671.
What company makes Pitch PaSoft Tissue Reinforcement Device?
Pitch PaSoft Tissue Reinforcement Device is manufactured by Xiros, Ltd..
What is the FDA product code for Pitch PaSoft Tissue Reinforcement Device?
The FDA product code for Pitch PaSoft Tissue Reinforcement Device is FTL.
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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.