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510(k) K200745

Lariat, Hot/Cold Snare by United States Endoscopy Group, Inc. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2020
Date Received
March 23, 2020
Clearance Type
Special
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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  • K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare (October 8, 2020)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)