K241502
- 510(k) number
- K241502
- Device name
- P-SCOPE
- Applicant
- Oui Medical, Inc. TX · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-07-24
- Date received
- 2024-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241502.pdf
Official FDA record: K241502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.