FDA 510(k)

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

Numéro K : K242128 · 2025-02-27

Date de décision2025-02-27

Code produitKNW

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) is the device name listed in this FDA 510(k) record. The listed applicant is Xaga Surgical. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K242128. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)?

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Xaga Surgical. The 510(k) number is K242128.

When did Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) receive FDA 510(k) clearance?

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) received FDA 510(k) clearance on 2025-02-27, under 510(k) number K242128.

Who is the listed applicant for Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)?

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

What is the FDA product code for Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)?

The FDA product code for Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) is KNW.

Essais cliniques associés

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Dispositifs connexes (Code : KNW)

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Source officielle

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