# FDA 483 - Iconocare Health - October 28, 2024

Source: https://www.keypedia.com/records/483/iconocare-health/2ae5dd77-1f4b-4469-8ec8-03ebf3b96b9b

> FDA 483 for Iconocare Health on October 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Iconocare Health
- Inspection Date: 2024-10-28
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Officers

- [Gabrielle Clark-Patterson](https://www.keypedia.com/people/gabrielle-clark-patterson/ecf7de67-e132-4b05-91fe-7e5b2a1178ec)

Company: https://www.keypedia.com/companies/iconocare-health/9770f199-85fc-43f3-bf7e-235ee215d061

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4