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FDA 510(k)

ADVANCED UROSCIENCE INJECTION NEEDLE

K-Number: K982890 · 1998-10-26

ApplicantAdvanced Uroscience, Inc.
Decision Date1998-10-26
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADVANCED UROSCIENCE INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Uroscience, Inc.. It received FDA 510(k) clearance on 1998-10-26 under 510(k) number K982890. 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 ADVANCED UROSCIENCE INJECTION NEEDLE?

ADVANCED UROSCIENCE INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1998-10-26. The listed applicant is Advanced Uroscience, Inc.. The 510(k) number is K982890.

When did ADVANCED UROSCIENCE INJECTION NEEDLE receive FDA 510(k) clearance?

ADVANCED UROSCIENCE INJECTION NEEDLE received FDA 510(k) clearance on 1998-10-26, under 510(k) number K982890.

Who is the listed applicant for ADVANCED UROSCIENCE INJECTION NEEDLE?

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

What is the FDA product code for ADVANCED UROSCIENCE INJECTION NEEDLE?

The FDA product code for ADVANCED UROSCIENCE INJECTION 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 Advanced Uroscience, Inc. 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.

K001807TISSUE MARKERK002573ADVANCED UROSCIENCE INNERSHEATHK002323ADVANCED UROSCIENCE INJECTION NEEDLEK993459MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

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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