Y ADAPTOR— 510(k) K910321

Substantially Equivalent

Akcess Medical Products, Inc.

FDA 510(k) clearance K910321 for Y ADAPTOR, Substantially Equivalent on 1991-04-16. Applicant: Akcess Medical Products, Inc..

Clearance details

Applicant: Akcess Medical Products, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1991-01-24
Decision date: 1991-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.