InjecSURE Injection System— 510(k) K253598

Name: FDA 510(k) clearance K253598
Creator: U.S. Food and Drug Administration
Published: 2026-03-31

Substantially Equivalent

Carbon Medical Technologies, Inc.

FDA 510(k) clearance K253598 for InjecSURE Injection System, Substantially Equivalent on 2026-03-31. Applicant: Carbon Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Carbon Medical Technologies, Inc.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-18
Decision date: 2026-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K241595 — EzVu Visual Vasopressor injector (EV-19)2025-02-27
K240675 — Endoscopic Injection Needles2024-10-04

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K132064 — BIOMARC FIDUCIAL MARKER2014-02-28

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.