CORE-CLIP— 510(k) K213338

Substantially Equivalent

Incore Co., Ltd.

FDA 510(k) clearance K213338 for CORE-CLIP, Substantially Equivalent on 2022-06-23. Applicant: Incore Co., Ltd..

Clearance details

Applicant: Incore Co., Ltd.
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2021-10-07
Decision date: 2022-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.