K252584
- 510(k) number
- K252584
- Device name
- Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
- Applicant
- Weyo Surgical Technology , Ltd. CN
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2026-06-25
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252584.pdf
Official FDA record: K252584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.