← Product Code [KGN](/productcode/KGN) · K260652

# ColActive Plus (K260652)

_Covalon Technologies, Ltd. · KGN · Sep 9, 2026 · SU · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K260652

## Device Facts

- **Applicant:** Covalon Technologies, Ltd.
- **Product Code:** [KGN](/productcode/KGN.md)
- **Decision Date:** Sep 9, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU

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**Source:** [https://fda-staging.innolitics.com/device/K260652](https://fda-staging.innolitics.com/device/K260652)

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