510(k) K253598
K253598 is an FDA 510(k) premarket notification submitted by Carbon Medical Technologies, Inc. for the device "InjecSURE Injection System". The FDA issued a decision of Substantially Equivalent on March 31, 2026. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Carbon Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2026
- Date Received
- November 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.