Insufflator— 510(k) K222812

Substantially Equivalent

Scivita Medical Technology Co., Ltd.

FDA 510(k) clearance K222812 for Insufflator, Substantially Equivalent on 2023-05-16. Applicant: Scivita Medical Technology Co., Ltd..

Clearance details

Applicant: Scivita Medical Technology Co., Ltd.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2022-09-19
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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.