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510(k) K190829

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2019
Date Received
April 1, 2019
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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  • K171993 — Zimmon Needle Knife Papillotome (August 17, 2017)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K121505 — DISPOSABLE HEMOSTASIS CHIP (August 31, 2012)
  • K111895 — ECHOTIP(R) ULTRA FIDUCIAL NEEDLE (April 27, 2012)

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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)