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510(k) K150316

Polypectomy Snare by Micro-Tech (Nanjing) Co., Ltd. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2015
Date Received
February 9, 2015
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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Other clearances for product code FDI

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  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)