510(k) K231342— Insufflator (OPTO-IFL1000)

Substantially Equivalent

Guangdong Optomedic Technologies, Inc.

Clearance details

Applicant: Guangdong Optomedic Technologies, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2023-05-09
Decision date: 2023-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

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.