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FDA 510(k)

Resitu Slider 09 (RESL09)

K-Number: K252183 · 2025-09-24

ApplicantResitu Medical AB
Decision Date2025-09-24
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Resitu Slider 09 (RESL09) is a medical device manufactured by Resitu Medical AB. It received FDA 510(k) clearance on 2025-09-24 under approval number K252183. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resitu Slider 09 (RESL09)?

Resitu Slider 09 (RESL09) is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by Resitu Medical AB. The 510(k) number is K252183.

When was Resitu Slider 09 (RESL09) approved by the FDA?

Resitu Slider 09 (RESL09) received FDA 510(k) clearance on 2025-09-24, under approval number K252183.

What company makes Resitu Slider 09 (RESL09)?

Resitu Slider 09 (RESL09) is manufactured by Resitu Medical AB.

What is the FDA product code for Resitu Slider 09 (RESL09)?

The FDA product code for Resitu Slider 09 (RESL09) is KNW.

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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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