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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 the device name listed in this FDA 510(k) record. The listed applicant is Resitu Medical AB. It received FDA 510(k) clearance on 2025-09-24 under 510(k) 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. The listed applicant is Resitu Medical AB. The 510(k) number is K252183.

When did Resitu Slider 09 (RESL09) receive FDA 510(k) clearance?

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

Who is the listed applicant for Resitu Slider 09 (RESL09)?

The FDA 510(k) record lists Resitu Medical AB as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KNW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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