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510(k) K070129

SONOTIP II ULTRASOUND NEEDLE SYSTEM by Medi-Globe Corporation — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2007
Date Received
January 16, 2007
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

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  • K091257 — MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM (May 8, 2009)
  • K083802 — SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27 (March 20, 2009)
  • K061684 — MEDI-GLOBE ROTA-CUT SPHINCTEROTOME (June 27, 2006)

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  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
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