InjecSURE Injection System
FDA 510(k) K253598 · Carbon Medical Technologies, Inc.
510(k) numberK253598
Submission
- Device name
- InjecSURE Injection System
- Applicant
- Carbon Medical Technologies, Inc.
St. Paul, MN, US - Received
- November 18, 2025
- Decision date
- March 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBK – Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Other 510(k)s with product code FBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260262 | Injection NeedleFBK · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 05/29/2026SE |
| K252021 | Disposable Endoscopic Injection NeedlesFBK · Traditional | Changzhou New Med Micro-Medtech Co., Ltd. | 12/02/2025SE |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…FBK · Traditional | Olympus Medical Systems Corporation | 10/16/2025SE |
| K241595 | EzVu Visual Vasopressor injector (EV-19)FBK · Traditional | Veol Medical Technologies Pvt , Ltd. | 02/27/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 10/04/2024SE |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | Laborie Medical Technologies, Corp. | 08/27/2024SE |
| K232200 | Disposable Injection NeedlesFBK · Traditional | Ningbo Xinwell Medical Technology Co., Ltd. | 04/12/2024SE |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…FBK · Traditional | Steris | 03/08/2024SE |
| K232442 | Disposable Endoscope Injection NeedlesFBK · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 11/09/2023SE |
| K230925 | Disposable Injection Needle AF seriesFBK · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 09/27/2023SE |
More from Alton (Shanghai) Medical Instruments Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | 07/23/2025SE |
| K211590 | Fiducial MarkerIYE · Special | 06/10/2021SE |
| K191797 | BiomarC Fiducial MarkerIYE · Special | 07/29/2019SE |
| K172227 | Endoscopic Injection NeedleFBK · Special | 08/23/2017SE |
| K133148 | Biomarc Coaxial NeedleFBK · Traditional | 05/13/2014SE |
| K132064 | Biomarc Fiducial MarkerIYE · Traditional | 02/28/2014SE |
| K132708 | Biomarc Fiducial MarkerNEU · Traditional | 12/20/2013SE |
| K130678 | Biomarc Gold Fiducial MarkerIYE · Special | 04/12/2013SE |
| K110772 | Biomarc Fiducial MarkerIYE · Traditional | 04/28/2011SE |
| K100994 | Preloaded Tissue Marker DeviceNEU · Special | 04/30/2010SE |
Questions and answers
When was InjecSURE Injection System cleared by the FDA?
InjecSURE Injection System (K253598) received a 510(k) decision of Substantially Equivalent on March 31, 2026, 133 days after the submission was received.
What is the product code of K253598?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.