K-number	K252183
Device name	Resitu Slider 09 (RESL09)
Applicant	Resitu Medical AB
Product code	KNW
Device class	Class II
Decision date	Sep 24, 2025
Decision	Substantially Equivalent
Regulation	876.1075

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Resitu Slider 09 (RESL09) is a biopsy instrument intended to provide breast tissue for diagnostic analysis of imaged abnormalities. It is used by healthcare professionals to obtain tissue samples from breast lesions identified on imaging for pathological examination.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated.

Substantial equivalence argument

The device is classified as a gastroenterology-urology biopsy instrument (21 CFR 876.1075) and is substantially equivalent to legally marketed predicate devices. The substantial equivalence is based on the device serving the same intended use of obtaining tissue samples for diagnostic analysis, with equivalent technological characteristics and design that do not raise new safety or effectiveness questions.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Resitu Slider 09 (RESL09)

Everything you need for a 510(k) submission. Nothing you don't.