InjecSURE Injection System— 510(k) K253598
Substantially EquivalentCarbon 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.
Summary
Carbon Medical Technologies' InjecSURE Injection System is filed under FBK, endoscopic injection needles (gastroenterology-urology). The record doesn't list needle sizes or model numbers.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Carbon Medical Technologies filed from St. Paul, Minnesota. The decision came 133 calendar days after receipt (November 18, 2025 to March 31, 2026).
Clearance details
- Applicant
- Carbon Medical Technologies, Inc.
- Product code
- Product code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FBK
view allMore clearances from Carbon Medical Technologies, Inc.
view allAdverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.