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FDA 510(k)

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

K-Number: K190829 · 2019-12-19

ApplicantWilson-Cook Medical Inc./Cook Endoscopy
Decision Date2019-12-19
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190829. 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 Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K190829.

When did Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) receive FDA 510(k) clearance?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190829.

Who is the listed applicant for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is FBK.

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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

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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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