Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)— 510(k) K252584
Substantially EquivalentWeyo Surgical Technology , Ltd.
FDA 510(k) clearance K252584 for Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C), Substantially Equivalent on 2026-06-25. Applicant: Weyo Surgical Technology , Ltd.. Device class: 2.
Summary
Weyo Surgical Technology's clearance covers an insufflator in six wAlcor models: C50A, C50B, C50C, C35A, C35B, and C35C. It's filed under HIF, laparoscopic insufflators, and the record doesn't say how the models differ.
Class II, 21 CFR 884.1730. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Weyo filed from Nanjing, China. The decision came 314 calendar days after FDA received it (August 15, 2025 to June 25, 2026).
Clearance details
- Applicant
- Weyo Surgical Technology , Ltd.
- Product code
- Product code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code HIF
view allAdverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
Source: openFDA MAUDE database, through . 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.