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FDA 510(k)

HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES

K-Number: K010448 · 2001-05-16

ApplicantHorizons Intl. Corp.
Decision Date2001-05-16
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Horizons Intl. Corp.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K010448. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES?

HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Horizons Intl. Corp.. The 510(k) number is K010448.

When did HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES receive FDA 510(k) clearance?

HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES received FDA 510(k) clearance on 2001-05-16, under 510(k) number K010448.

Who is the listed applicant for HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES?

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

What is the FDA product code for HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES?

The FDA product code for HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES is FBK.

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Other records listing Horizons Intl. Corp. 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.

K083049TORNADO ROTATABEL SNARE AND POLYP CATCHERK022243HORIZONS REUSABLE HOT BIOPSY FORCEPSK022268HORIZONS REUSABLE POLYPECTOMY SNARESK022546HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLESK021998HORIZONS CYTOLOGY BRUSHK021706HORIZONS HOT BIOPSY FORCEPS

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Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech 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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