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FDA 510(k)

Small Volume 0.2mL Syringe

K-Number: K250138 · 2025-04-02

ApplicantProsum Medical Limited
Decision Date2025-04-02
Product CodeQNQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Small Volume 0.2mL Syringe is a medical device manufactured by Prosum Medical Limited. It received FDA 510(k) clearance on 2025-04-02 under approval number K250138. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Small Volume 0.2mL Syringe?

Small Volume 0.2mL Syringe is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by Prosum Medical Limited. The 510(k) number is K250138.

When was Small Volume 0.2mL Syringe approved by the FDA?

Small Volume 0.2mL Syringe received FDA 510(k) clearance on 2025-04-02, under approval number K250138.

What company makes Small Volume 0.2mL Syringe?

Small Volume 0.2mL Syringe is manufactured by Prosum Medical Limited.

What is the FDA product code for Small Volume 0.2mL Syringe?

The FDA product code for Small Volume 0.2mL Syringe is QNQ.

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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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