483
Iconocare HealthFDA 483 - Iconocare Health - October 28, 2024
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Record Details
Iconocare Health received an FDA Request for Additional Information for their 510(k) premarket notification K242610 for 8mm Monopolar Curved Scissors. The submission is on hold due to major deficiencies, and the firm must submit a complete response within 180 days to avoid withdrawal. The device cannot be marketed without FDA clearance.
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ID · 2ae5dd77-1f4b-4469-8ec8-03ebf3b96b9b