510(k) K953290— OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP

Substantially Equivalent

Olympus America, Inc.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1995-07-14
Decision date: 1995-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Adverse events under product code KZD

product code KZD

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.