DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900— 510(k) K921963

Substantially Equivalent

Sun Medical, Inc.

FDA 510(k) clearance K921963 for DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900, Substantially Equivalent on 1992-09-11. Applicant: Sun Medical, Inc..

Clearance details

Applicant: Sun Medical, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1992-04-27
Decision date: 1992-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

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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.