Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InjecSURE Injection System

K-Number: K253598 · 2026-03-31

ApplicantCarbon Medical Technologies, Inc.
Decision Date2026-03-31
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

InjecSURE Injection System is a medical device manufactured by Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2026-03-31 under approval number K253598. 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 InjecSURE Injection System?

InjecSURE Injection System is a medical device that received FDA 510(k) clearance on 2026-03-31. It is manufactured by Carbon Medical Technologies, Inc.. The 510(k) number is K253598.

When was InjecSURE Injection System approved by the FDA?

InjecSURE Injection System received FDA 510(k) clearance on 2026-03-31, under approval number K253598.

What company makes InjecSURE Injection System?

InjecSURE Injection System is manufactured by Carbon Medical Technologies, Inc..

What is the FDA product code for InjecSURE Injection System?

The FDA product code for InjecSURE Injection System is FBK.

Related Clinical Trials

NCT07224464 The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. RECRUITING 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 NCT03067051 Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System RECRUITING NCT05562947 A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD) RECRUITING

Other Devices by Carbon Medical Technologies, Inc.

K172227Endoscopic Injection Needle K211590Fiducial Marker K251748MammoSTAR Biopsy Site Identifier 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. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix 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.

↑