FDA 510(k)

Mammotome AutoCore Single Insertion Core Biopsy System

K-Number: K243095 · 2024-10-29

Decision Date2024-10-29

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Mammotome AutoCore Single Insertion Core Biopsy System is a medical device manufactured by Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2024-10-29 under approval number K243095. 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 Mammotome AutoCore Single Insertion Core Biopsy System?

Mammotome AutoCore Single Insertion Core Biopsy System is a medical device that received FDA 510(k) clearance on 2024-10-29. It is manufactured by Devicor Medical Products, Inc.. The 510(k) number is K243095.

When was Mammotome AutoCore Single Insertion Core Biopsy System approved by the FDA?

Mammotome AutoCore Single Insertion Core Biopsy System received FDA 510(k) clearance on 2024-10-29, under approval number K243095.

What company makes Mammotome AutoCore Single Insertion Core Biopsy System?

Mammotome AutoCore Single Insertion Core Biopsy System is manufactured by Devicor Medical Products, Inc..

What is the FDA product code for Mammotome AutoCore Single Insertion Core Biopsy System?

The FDA product code for Mammotome AutoCore Single Insertion Core Biopsy System is KNW.

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Related Devices (Code: 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.