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FDA 510(k)

VARICES NEEDLE

K-Number: K031238 · 2004-10-04

ApplicantScandimed. A.S.
Decision Date2004-10-04
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VARICES NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Scandimed. A.S.. It received FDA 510(k) clearance on 2004-10-04 under 510(k) number K031238. 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 VARICES NEEDLE?

VARICES NEEDLE is a medical device that received FDA 510(k) clearance on 2004-10-04. The listed applicant is Scandimed. A.S.. The 510(k) number is K031238.

When did VARICES NEEDLE receive FDA 510(k) clearance?

VARICES NEEDLE received FDA 510(k) clearance on 2004-10-04, under 510(k) number K031238.

Who is the listed applicant for VARICES NEEDLE?

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

What is the FDA product code for VARICES NEEDLE?

The FDA product code for VARICES NEEDLE is FBK.

Related Clinical Trials

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.

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Other records listing Scandimed. A.S. 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.

K031236AUTO-BAND LIGATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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