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510(k) K133148

BIOMARC COAXIAL NEEDLE by Carbon Medical Technologies, Inc. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2014
Date Received
October 17, 2013
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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  • 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)
  • K070436 — BIOMARC GOLD TISSUE MARKER (March 16, 2007)

Other clearances for product code FBK

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  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • 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)