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FDA 510(k)

MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE

K-Number: K063613 · 2006-12-26

ApplicantTerumo Medical Corp.
Decision Date2006-12-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2006-12-26 under 510(k) number K063613. 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 MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE?

MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE is a medical device that received FDA 510(k) clearance on 2006-12-26. The listed applicant is Terumo Medical Corp.. The 510(k) number is K063613.

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

MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE received FDA 510(k) clearance on 2006-12-26, under 510(k) number K063613.

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

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

What is the FDA product code for MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE?

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

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Other records listing Terumo Medical Corp. as applicant

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K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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