CORE-SNARE— 510(k) K220846

Name: FDA 510(k) clearance K220846
Creator: U.S. Food and Drug Administration
Published: 2022-11-21

Substantially Equivalent

Incore Co., Ltd.

FDA 510(k) clearance K220846 for CORE-SNARE, Substantially Equivalent on 2022-11-21. Applicant: Incore Co., Ltd.. Device class: 2.

Clearance details

Applicant: Incore Co., Ltd.
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2022-03-23
Decision date: 2022-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code FDI

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K251692 — Advanced Tissue Resection Device2026-02-21
K221713 — Polypectomy Snare2023-03-03
K220089 — Disposable Polyp Snare2022-09-22
K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare2022-06-27
K213222 — Disposable Polypectomy Snare2022-06-06

More clearances from Incore Co., Ltd.

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K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC)2024-04-19
K221054 — CORE-INJECTOR2022-12-21
K220081 — CORE-SPORT2022-09-28
K213338 — CORE-CLIP2022-06-23
K211148 — CORE-Trocar2022-06-21

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.