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FDA 510(k)

MONOJECT 12ML SYRINGE

K-Number: K130049 · 2013-02-14

ApplicantNipro Medical Corporation
Decision Date2013-02-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONOJECT 12ML SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K130049. 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 MONOJECT 12ML SYRINGE?

MONOJECT 12ML SYRINGE is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Nipro Medical Corporation. The 510(k) number is K130049.

When did MONOJECT 12ML SYRINGE receive FDA 510(k) clearance?

MONOJECT 12ML SYRINGE received FDA 510(k) clearance on 2013-02-14, under 510(k) number K130049.

Who is the listed applicant for MONOJECT 12ML SYRINGE?

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

What is the FDA product code for MONOJECT 12ML SYRINGE?

The FDA product code for MONOJECT 12ML SYRINGE is FMF.

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Other records listing Nipro Medical Corporation as applicant

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.

K261399ELISIO™-HXK253047PRESSONE™K260533ELISIO™-HK222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleK212677aboNT SYRINGEK190037Cronus HP PTA Balloon 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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