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510(k) K253598

InjecSURE Injection System by Carbon Medical Technologies, Inc. — Product Code FBK

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.

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  • K133148 — BIOMARC COAXIAL NEEDLE (May 13, 2014)
  • K132064 — BIOMARC FIDUCIAL MARKER (February 28, 2014)
  • K132708 — BIOMARC FIDUCIAL MARKER (December 20, 2013)
  • K130678 — BIOMARC GOLD FIDUCIAL MARKER (April 12, 2013)
  • K110772 — BIOMARC FIDUCIAL MARKER (April 28, 2011)
  • K100994 — PRELOADED TISSUE MARKER DEVICE (April 30, 2010)

Other clearances for product code FBK

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  • K232200 — Disposable Injection Needles (April 12, 2024)
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  • K232442 — Disposable Endoscope Injection Needles (November 9, 2023)
  • K230925 — Disposable Injection Needle AF series (September 27, 2023)
  • K222006 — Sclerotherapy & Endoscopic Needles (April 3, 2023)