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FDA 510(k)

DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES

K-Number: K861153 · 1986-04-23

ApplicantExel Intl.
Decision Date1986-04-23
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Exel Intl.. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K861153. 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 DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES?

DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Exel Intl.. The 510(k) number is K861153.

When did DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES receive FDA 510(k) clearance?

DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES received FDA 510(k) clearance on 1986-04-23, under 510(k) number K861153.

Who is the listed applicant for DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES?

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

What is the FDA product code for DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES?

The FDA product code for DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES is FMF.

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Other records listing Exel Intl. 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.

K992290EXEL INJECTION PLUG WITH CAPK963658EXEL AVF SINGLE NEEDLEK963659EXEL I.V. ADMINISTRATION SETK926119EXEL HUBER INFUSION SET ROTATING WINGK904685EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)K903945EXEL A-V FISTULA SET

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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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