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FDA 510(k)

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

K-Number: K161409 · 2016-08-02

ApplicantMermaid Medical A/S
Decision Date2016-08-02
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is a medical device manufactured by Mermaid Medical A/S. It received FDA 510(k) clearance on 2016-08-02 under approval number K161409. 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 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is a medical device that received FDA 510(k) clearance on 2016-08-02. It is manufactured by Mermaid Medical A/S. The 510(k) number is K161409.

When was M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem approved by the FDA?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem received FDA 510(k) clearance on 2016-08-02, under approval number K161409.

What company makes M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is manufactured by Mermaid Medical A/S.

What is the FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem 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.

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