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510(k) K220846

CORE-SNARE by Incore Co., Ltd. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2022
Date Received
March 23, 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 Incore Co., Ltd.

  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K221054 — CORE-INJECTOR (December 21, 2022)
  • K220081 — CORE-SPORT (September 28, 2022)
  • K213338 — CORE-CLIP (June 23, 2022)
  • K211148 — CORE-Trocar (June 21, 2022)

Other clearances for product code FDI

  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • 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)