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510(k) K142258

PolyCatch Retrieval Device by Medi-Globe Corporation — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2014
Date Received
August 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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  • 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)

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