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FDA 510(k)

Clear-Jet Injection Catheter

K-Number: K181690 · 2018-12-21

ApplicantFinemedix Co., Ltd.
Decision Date2018-12-21
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Clear-Jet Injection Catheter is a medical device manufactured by Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under approval number K181690. 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 Clear-Jet Injection Catheter?

Clear-Jet Injection Catheter is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K181690.

When was Clear-Jet Injection Catheter approved by the FDA?

Clear-Jet Injection Catheter received FDA 510(k) clearance on 2018-12-21, under approval number K181690.

What company makes Clear-Jet Injection Catheter?

Clear-Jet Injection Catheter is manufactured by Finemedix Co., Ltd..

What is the FDA product code for Clear-Jet Injection Catheter?

The FDA product code for Clear-Jet Injection Catheter is FBK.

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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 K180214Repris Bladder Injection SystemUro-1, Inc.

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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