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FDA 510(k)

Terumo Injection Filter Needle (NF-3013RBKE05M)

K-Number: K230951 · 2023-10-18

ApplicantTerumo Europe N.V.
Decision Date2023-10-18
Product CodeQYM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Terumo Injection Filter Needle (NF-3013RBKE05M) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2023-10-18 under 510(k) number K230951. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Terumo Injection Filter Needle (NF-3013RBKE05M)?

Terumo Injection Filter Needle (NF-3013RBKE05M) is a medical device that received FDA 510(k) clearance on 2023-10-18. The listed applicant is Terumo Europe N.V.. The 510(k) number is K230951.

When did Terumo Injection Filter Needle (NF-3013RBKE05M) receive FDA 510(k) clearance?

Terumo Injection Filter Needle (NF-3013RBKE05M) received FDA 510(k) clearance on 2023-10-18, under 510(k) number K230951.

Who is the listed applicant for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M) is QYM.

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Related Devices (Code: QYM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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