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510(k) K172227

Endoscopic Injection Needle by Carbon Medical Technologies, Inc. — Product Code FBK

K172227 is an FDA 510(k) premarket notification submitted by Carbon Medical Technologies, Inc. for the device "Endoscopic Injection Needle". The FDA issued a decision of Substantially Equivalent on August 23, 2017. 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
August 23, 2017
Date Received
July 25, 2017
Clearance Type
Special
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.

Other clearances by Carbon Medical Technologies, Inc.

  • K253598 — InjecSURE Injection System (March 31, 2026)
  • K251748 — MammoSTAR Biopsy Site Identifier (July 23, 2025)
  • K211590 — Fiducial Marker (June 10, 2021)
  • K191797 — BiomarC Fiducial Marker (July 29, 2019)
  • 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

  • K260262 — Injection Needle (May 29, 2026)
  • K253598 — InjecSURE Injection System (March 31, 2026)
  • K252021 — Disposable Endoscopic Injection Needles (December 2, 2025)
  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K241595 — EzVu Visual Vasopressor injector (EV-19) (February 27, 2025)
  • K240675 — Endoscopic Injection Needles (October 4, 2024)
  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • K232200 — Disposable Injection Needles (April 12, 2024)
  • K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810) (March 8, 2024)
  • K232442 — Disposable Endoscope Injection Needles (November 9, 2023)

FDA data resources