K231342
- 510(k) number
- K231342
- Device name
- Insufflator (OPTO-IFL1000)
- Applicant
- Guangdong Optomedic Technologies, Inc. CN
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2023-09-20
- Date received
- 2023-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231342.pdf
Official FDA record: K231342
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.