(Roth)Spiral Rotating Prostatic Biopsy Needle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863385 ↗

FDA Product Code

KNN

Device Class

Class I

Regulation

21 CFR Part 890.3920

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K961904 Active Cleared 18 Oct 1996

• Bipolar Cutter

  Class II

  FDA 510(k) K955618 Active Cleared 22 Jan 1996

• Rutner Biopsy Device

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  FDA 510(k) K950810 Active Cleared 6 Mar 1995

• CO2 Pneumo-Dissector

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• Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

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See all devices from Cook Urological, Inc. →