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510(k) K091257

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM by Medi-Globe Corporation — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2009
Date Received
April 29, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Medi-Globe Corporation

  • K153264 — EasyPass Guidewire (May 19, 2016)
  • K142258 — PolyCatch Retrieval Device (September 30, 2014)
  • K133763 — SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM (May 15, 2014)
  • K083802 — SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27 (March 20, 2009)
  • K070129 — SONOTIP II ULTRASOUND NEEDLE SYSTEM (January 31, 2007)
  • K061684 — MEDI-GLOBE ROTA-CUT SPHINCTEROTOME (June 27, 2006)

Other clearances for product code FCG

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  • 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)