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FDA 510(k)

WILTEK VARICES INJECTION NEEDLE

K-Number: K894868 · 1989-12-21

ApplicantWiltek Medical, Inc.
Decision Date1989-12-21
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK VARICES INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K894868. 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 WILTEK VARICES INJECTION NEEDLE?

WILTEK VARICES INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K894868.

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

WILTEK VARICES INJECTION NEEDLE received FDA 510(k) clearance on 1989-12-21, under 510(k) number K894868.

Who is the listed applicant for WILTEK VARICES INJECTION NEEDLE?

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

What is the FDA product code for WILTEK VARICES INJECTION NEEDLE?

The FDA product code for WILTEK VARICES INJECTION NEEDLE is FBK.

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Other records listing Wiltek Medical, Inc. as applicant

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K990231WILTEK HOT BIOPSY FORCEPSK922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTOR

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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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