XOMED MICRO-IRRIGATOR— 510(k) K813475

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K813475 for XOMED MICRO-IRRIGATOR, Substantially Equivalent on 1982-02-04. Applicant: Xomed, Inc..

Clearance details

Applicant: Xomed, Inc.
Product code: Code FQH
Advisory panel: General Hospital
Date received: 1981-12-01
Decision date: 1982-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.