INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330— 510(k) K092129

Substantially Equivalent

Intersurgical, Inc.

FDA 510(k) clearance K092129 for INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330, Substantially Equivalent on 2010-05-18. Applicant: Intersurgical, Inc..

Clearance details

Applicant: Intersurgical, Inc.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2009-07-15
Decision date: 2010-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.