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510(k) K212423

EndoDrill® Model X by Bibbinstruments AB — Product Code FCG

K212423 is an FDA 510(k) premarket notification submitted by Bibbinstruments AB for the device "EndoDrill® Model X". The FDA issued a decision of Substantially Equivalent on March 29, 2023. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2023
Date Received
August 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances for product code FCG

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  • K250994 — ClearTip FNA and FNB Types (August 21, 2025)
  • K241209 — EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (July 29, 2024)
  • K231422 — Precision GI (August 28, 2023)
  • K231267 — ClearTip (June 30, 2023)
  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)
  • K191472 — Biopsy Needle (January 29, 2020)

FDA data resources