K253598
- 510(k) number
- K253598
- Device name
- InjecSURE Injection System
- Applicant
- Carbon Medical Technologies, Inc. MN · US
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2026-03-31
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K253598.pdf
Official FDA record: K253598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.