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510(k) K990220

MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM by Medi-Globe Corp. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1999
Date Received
January 22, 1999
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 by Medi-Globe Corp.

  • K061222 — INJECTRA INJECTION NEEDLE (July 3, 2006)
  • K051247 — SONOTIP II ULTRASOUND NEEDLE SYSTEM (June 16, 2005)
  • K011261 — STONE EXTRACTOR BALLOON CATHETER (November 17, 2003)
  • K010714 — EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (January 21, 2003)
  • K010549 — BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) (January 18, 2002)
  • K953355 — GIP/MEID-GLOBE HOT BIOPSY FORCEPS (April 4, 1996)
  • K955558 — GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES (February 29, 1996)
  • K953827 — GIP/MEDI-GLOBE ERCP CATHETERS (September 1, 1995)
  • K941973 — GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES (June 30, 1995)
  • K943629 — GIP/MEDI-GLOBE PAPILLOTOME (May 26, 1995)

Other clearances for product code FCG

  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • 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)
  • K212423 — EndoDrill® Model X (March 29, 2023)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)