ON-Q INTRODUCERS— 510(k) K063234

Substantially Equivalent

I-Flow Corp.

FDA 510(k) clearance K063234 for ON-Q INTRODUCERS, Substantially Equivalent on 2006-11-21. Applicant: I-Flow Corp..

Clearance details

Applicant: I-Flow Corp.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2006-10-25
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.