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510(k) K221054

CORE-INJECTOR by Incore Co., Ltd. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2022
Date Received
April 11, 2022
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.

Other clearances by Incore Co., Ltd.

  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K220081 — CORE-SPORT (September 28, 2022)
  • K213338 — CORE-CLIP (June 23, 2022)
  • K211148 — CORE-Trocar (June 21, 2022)

Other clearances for product code FBK

  • 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)
  • K230925 — Disposable Injection Needle AF series (September 27, 2023)
  • K222006 — Sclerotherapy & Endoscopic Needles (April 3, 2023)