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510(k) K191048

AcuSnare Polypectomy Snare - Duckbill by Wilson-Cook Medical, Inc. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2019
Date Received
April 19, 2019
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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  • K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB- (October 7, 2021)
  • K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare (October 8, 2020)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)