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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 a medical device manufactured by Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2019-12-19 under approval 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. It is manufactured by Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K190829.

When was Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) approved by the FDA?

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

What company makes Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is manufactured by Wilson-Cook Medical Inc./Cook Endoscopy.

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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Other Devices by Wilson-Cook Medical Inc./Cook Endoscopy

K171993Zimmon Needle Knife Papillotome K171607Bronchi and Gastrointestinal Cytology Brush K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords K172288Fusion OMNI Sphincterotome

Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix 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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