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FDA 510(k)

Endoscopic Injection Needle

K-Number: K172227 · 2017-08-23

ApplicantCarbon Medical Technologies, Inc.
Decision Date2017-08-23
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) number K172227. 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 Endoscopic Injection Needle?

Endoscopic Injection Needle is a medical device that received FDA 510(k) clearance on 2017-08-23. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K172227.

When did Endoscopic Injection Needle receive FDA 510(k) clearance?

Endoscopic Injection Needle received FDA 510(k) clearance on 2017-08-23, under 510(k) number K172227.

Who is the listed applicant for Endoscopic Injection Needle?

The FDA 510(k) record lists Carbon Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscopic Injection Needle?

The FDA product code for Endoscopic Injection Needle is FBK.

Related Clinical Trials

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.

NCT07754955Comparison of Efficacy and Safety of Speedboat Device and Needle Knife for Colorectal Endoscopic Submucosal Dissection: a Multicenter Randomized StudyRECRUITING

Other records listing Carbon Medical Technologies, Inc. as applicant

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.

K253598InjecSURE Injection SystemPMA P980053AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USEK251748MammoSTAR Biopsy Site IdentifierK211590Fiducial MarkerK191797BiomarC Fiducial Marker

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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