Jewel Soft Tissue Reinforcement Device (102-6005)— 510(k) K242237

Name: FDA 510(k) clearance K242237
Creator: U.S. Food and Drug Administration
Published: 2025-07-15

Substantially Equivalent

Xiros Limited

FDA 510(k) clearance K242237 for Jewel Soft Tissue Reinforcement Device (102-6005), Substantially Equivalent on 2025-07-15. Applicant: Xiros Limited. Device class: 2.

Clearance details

Applicant: Xiros Limited
Product code: Code QUW
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2024-07-30
Decision date: 2025-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yeadon, GB

Download summary PDF View on FDA.gov ↗

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