ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC— 510(k) K022480

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K022480 for ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC, Substantially Equivalent on 2002-08-22. Applicant: Acmi Corporation.

Clearance details

Applicant: Acmi Corporation
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2002-07-26
Decision date: 2002-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.