510(k) K252584— Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

Substantially Equivalent

Weyo Surgical Technology , Ltd.

Clearance details

Applicant: Weyo Surgical Technology , Ltd.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2025-08-15
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, 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.