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FDA 510(k)

TERUMO SYRINGE WITH/WITHOUT NEEDLE

K-Number: K083514 · 2009-05-22

ApplicantTerumo Europe N.V.
Decision Date2009-05-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO SYRINGE WITH/WITHOUT NEEDLE 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 2009-05-22 under 510(k) number K083514. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO SYRINGE WITH/WITHOUT NEEDLE?

TERUMO SYRINGE WITH/WITHOUT NEEDLE is a medical device that received FDA 510(k) clearance on 2009-05-22. The listed applicant is Terumo Europe N.V.. The 510(k) number is K083514.

When did TERUMO SYRINGE WITH/WITHOUT NEEDLE receive FDA 510(k) clearance?

TERUMO SYRINGE WITH/WITHOUT NEEDLE received FDA 510(k) clearance on 2009-05-22, under 510(k) number K083514.

Who is the listed applicant for TERUMO SYRINGE WITH/WITHOUT NEEDLE?

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 SYRINGE WITH/WITHOUT NEEDLE?

The FDA product code for TERUMO SYRINGE WITH/WITHOUT NEEDLE is FMF.

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Other records listing Terumo Europe N.V. as applicant

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K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)K230951Terumo Injection Filter Needle (NF-3013RBKE05M)K212095SurGuard3 Safety Hypodermic NeedleK192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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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