AMUKIN-50% FOR CAPD Y-SET— 510(k) K862928

Substantially Equivalent

Amuchina Intl., Inc.

FDA 510(k) clearance K862928 for AMUKIN-50% FOR CAPD Y-SET, Substantially Equivalent on 1987-03-09. Applicant: Amuchina Intl., Inc..

Clearance details

Applicant: Amuchina Intl., Inc.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1986-08-01
Decision date: 1987-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.