Home / 510(k) Clearances / K222006

510(k) K222006

Sclerotherapy & Endoscopic Needles by G-Flex Europe Sprl — Product Code FBK

K222006 is an FDA 510(k) premarket notification submitted by G-Flex Europe Sprl for the device "Sclerotherapy & Endoscopic Needles". The FDA issued a decision of Substantially Equivalent on April 3, 2023. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. G-Flex Europe Sprl has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2023
Date Received
July 7, 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 G-Flex Europe Sprl

  • K211909 — Cysto-Gastro-Sets (June 9, 2022)

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