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 a medical device manufactured by Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2017-08-23 under approval 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. It is manufactured by Carbon Medical Technologies, Inc.. The 510(k) number is K172227.

When was Endoscopic Injection Needle approved by the FDA?

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

What company makes Endoscopic Injection Needle?

Endoscopic Injection Needle is manufactured by Carbon Medical Technologies, Inc..

What is the FDA product code for Endoscopic Injection Needle?

The FDA product code for Endoscopic Injection Needle is FBK.

Related Clinical Trials

NCT03654066 Botox or Botox With Esophageal Dilation in Patients With Achalasia ENROLLING_BY_INVITATION NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06606587 Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia COMPLETED NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Other Devices by Carbon Medical Technologies, Inc.

K211590Fiducial Marker K251748MammoSTAR Biopsy Site Identifier K253598InjecSURE Injection System PMA P980053AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix Co., Ltd. K180214Repris Bladder Injection SystemUro-1, Inc.

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.