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FDA 510(k)

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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05264389Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) ReconstructionACTIVE_NOT_RECRUITINGNCT05906004Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator CuffRECRUITING

Other records listing Xiros Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230671Pitch PaSoft Tissue Reinforcement DeviceK222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220906SECURE-LOCKK211563Pitch-PatchsK191053Xtreme-Loop

View all 9 devices →

Related Devices (Code: QUW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicroK251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicroK222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.

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.

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