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510(k) K220089

Disposable Polyp Snare by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2022
Date Received
January 11, 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

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  • K230598 — Stone Extraction Baskets (September 12, 2023)
  • K222146 — Disposable Endoscopic Hemoclip (March 28, 2023)
  • K213914 — Injection Needle (July 29, 2022)

Other clearances for product code FDI

  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • K220846 — CORE-SNARE (November 21, 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)