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510(k) K221713

Polypectomy Snare by Hangzhou AGS MedTech Co., Ltd. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2023
Date Received
June 13, 2022
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

Other clearances by Hangzhou AGS MedTech Co., Ltd.

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  • K213143 — Hemoclip (July 12, 2022)
  • K213578 — Balloon Dilatation Catheter (April 6, 2022)
  • K211787 — Hemoclip (March 3, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K201121 — Sphincterotome (February 5, 2021)
  • K202237 — Locking device (December 23, 2020)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)

Other clearances for product code FDI

  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (June 27, 2022)
  • K213222 — Disposable Polypectomy Snare (June 6, 2022)
  • 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)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)