CORE-SPORT— 510(k) K220081

Substantially Equivalent

Incore Co., Ltd.

FDA 510(k) clearance K220081 for CORE-SPORT, Substantially Equivalent on 2022-09-28. Applicant: Incore Co., Ltd.. Device class: 2.

Clearance details

Applicant: Incore Co., Ltd.
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-01-10
Decision date: 2022-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Incore Co., Ltd.

K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC)2024-04-19
K221054 — CORE-INJECTOR2022-12-21
K220846 — CORE-SNARE2022-11-21
K213338 — CORE-CLIP2022-06-23
K211148 — CORE-Trocar2022-06-21

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