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FDA 510(k)

Interject Injection Therapy Needle Catheter

K-Number: K171454 · 2017-07-07

ApplicantBoston Scientific Corporation
Decision Date2017-07-07
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Interject Injection Therapy Needle Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-07-07 under approval number K171454. 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 Interject Injection Therapy Needle Catheter?

Interject Injection Therapy Needle Catheter is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Boston Scientific Corporation. The 510(k) number is K171454.

When was Interject Injection Therapy Needle Catheter approved by the FDA?

Interject Injection Therapy Needle Catheter received FDA 510(k) clearance on 2017-07-07, under approval number K171454.

What company makes Interject Injection Therapy Needle Catheter?

Interject Injection Therapy Needle Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Interject Injection Therapy Needle Catheter?

The FDA product code for Interject Injection Therapy Needle 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 K181690Clear-Jet Injection CatheterFinemedix Co., Ltd. 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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