ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R— 510(k) K200968

Substantially Equivalent

Insung Medical Co., Ltd.

FDA 510(k) clearance K200968 for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R, Substantially Equivalent on 2020-12-28. Applicant: Insung Medical Co., Ltd..

Clearance details

Applicant: Insung Medical Co., Ltd.
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2020-04-10
Decision date: 2020-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangwon-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.