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FDA 510(k)

ENTERYX INJECTION CATHETER

K-Number: K042882 · 2004-11-09

ApplicantBoston Scientific Corp
Decision Date2004-11-09
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTERYX INJECTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2004-11-09 under 510(k) number K042882. 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 ENTERYX INJECTION CATHETER?

ENTERYX INJECTION CATHETER is a medical device that received FDA 510(k) clearance on 2004-11-09. The listed applicant is Boston Scientific Corp. The 510(k) number is K042882.

When did ENTERYX INJECTION CATHETER receive FDA 510(k) clearance?

ENTERYX INJECTION CATHETER received FDA 510(k) clearance on 2004-11-09, under 510(k) number K042882.

Who is the listed applicant for ENTERYX INJECTION CATHETER?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERYX INJECTION CATHETER?

The FDA product code for ENTERYX INJECTION CATHETER 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

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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