Jewel Soft Tissue Reinforcement Device (102-6005)
K-Number: K242237 · 2025-07-15
ApplicantXiros Limited
Decision Date2025-07-15
Product CodeQUW
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Jewel Soft Tissue Reinforcement Device (102-6005) is a medical device manufactured by Xiros Limited. It received FDA 510(k) clearance on 2025-07-15 under approval number K242237. The device is classified under product code QUW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Jewel Soft Tissue Reinforcement Device (102-6005)?
Jewel Soft Tissue Reinforcement Device (102-6005) is a medical device that received FDA 510(k) clearance on 2025-07-15. It is manufactured by Xiros Limited. The 510(k) number is K242237.
When was Jewel Soft Tissue Reinforcement Device (102-6005) approved by the FDA?
Jewel Soft Tissue Reinforcement Device (102-6005) received FDA 510(k) clearance on 2025-07-15, under approval number K242237.
What company makes Jewel Soft Tissue Reinforcement Device (102-6005)?
Jewel Soft Tissue Reinforcement Device (102-6005) is manufactured by Xiros Limited.
What is the FDA product code for Jewel Soft Tissue Reinforcement Device (102-6005)?
The FDA product code for Jewel Soft Tissue Reinforcement Device (102-6005) is QUW.
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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.