MODIFIED LABELING FOR AMUKIN-50%— 510(k) K871583

Substantially Equivalent

Amuchina Intl., Inc.

FDA 510(k) clearance K871583 for MODIFIED LABELING FOR AMUKIN-50%, Substantially Equivalent on 1987-07-09. Applicant: Amuchina Intl., Inc..

Clearance details

Applicant: Amuchina Intl., Inc.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1987-04-23
Decision date: 1987-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.