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510(k) K252021

Disposable Endoscopic Injection Needles by Changzhou New Med Micro-Medtech Co., Ltd. — Product Code FBK

K252021 is an FDA 510(k) premarket notification submitted by Changzhou New Med Micro-Medtech Co., Ltd. for the device "Disposable Endoscopic Injection Needles". The FDA issued a decision of Substantially Equivalent on December 2, 2025. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2025
Date Received
June 30, 2025
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 for product code FBK

  • K260262 — Injection Needle (May 29, 2026)
  • K253598 — InjecSURE Injection System (March 31, 2026)
  • 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)

FDA data resources