K252318
- 510(k) number
- K252318
- Device name
- Insufflator (OPTO-IFL1000)
- Applicant
- Guangdong Optomedic Technologies, Inc. CN
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2026-04-16
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252318.pdf
Official FDA record: K252318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.