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FDA 510(k)

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

K-Number: K232943 · 2024-05-31

ApplicantSmiths Medical Asd, Inc.
Decision Date2024-05-31
Product CodeQNQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232943. 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 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K232943.

When did Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe receive FDA 510(k) clearance?

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232943.

Who is the listed applicant for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

The FDA product code for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is QNQ.

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Other records listing Smiths Medical Asd, Inc. as applicant

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Related Devices (Code: QNQ)

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.

K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.K250127TSK SyringeTsk Laboratory, JapanK250138Small Volume 0.2mL SyringeProsum Medical LimitedK242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd

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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