FDA 510(k)

Jewel Soft Tissue Reinforcement Device (102-6005)

Número K: K242237 · 2025-07-15

Data da decisão2025-07-15

Código do produtoQUW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Jewel Soft Tissue Reinforcement Device (102-6005) is the device name listed in this FDA 510(k) record. The listed applicant is Xiros Limited. It received FDA 510(k) clearance on 2025-07-15 under 510(k) number K242237. The device is classified under product code QUW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Xiros Limited. The 510(k) number is K242237.

When did Jewel Soft Tissue Reinforcement Device (102-6005) receive FDA 510(k) clearance?

Jewel Soft Tissue Reinforcement Device (102-6005) received FDA 510(k) clearance on 2025-07-15, under 510(k) number K242237.

Who is the listed applicant for Jewel Soft Tissue Reinforcement Device (102-6005)?

The FDA 510(k) record lists Xiros Limited as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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