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FDA 510(k)

WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE

K-Number: K865086 · 1987-03-10

ApplicantVan-Tec, Inc.
Decision Date1987-03-10
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Van-Tec, Inc.. It received FDA 510(k) clearance on 1987-03-10 under 510(k) number K865086. 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 WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE?

WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Van-Tec, Inc.. The 510(k) number is K865086.

When did WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE receive FDA 510(k) clearance?

WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE received FDA 510(k) clearance on 1987-03-10, under 510(k) number K865086.

Who is the listed applicant for WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE?

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

What is the FDA product code for WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE?

The FDA product code for WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE is FBK.

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Other records listing Van-Tec, 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.

K880096VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUPK880095BERGER PROSTATE CULTURE CYTOLOGY BRUSHK880098VAN-TEC AUTO BIOPSY NEEDLEK880099VAN-TEC BLADDER EVACUATORK880094VAN-TEC ENDOPYELOTOMY KNIFEK874112VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER

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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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