STRYKER HEATED INSUFFLATOR TUBE SET— 510(k) K003792

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K003792 for STRYKER HEATED INSUFFLATOR TUBE SET, Substantially Equivalent on 2001-02-21. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2000-12-08
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.