K232062
- 510(k) number
- K232062
- Device name
- Uni-port
- Applicant
- Dalim Medical Corp. KR
- Product code
- OTJ — Laparoscopic Single Port Access Device
- Decision date
- 2024-01-16
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232062.pdf
Official FDA record: K232062
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.