K250212
- 510(k) number
- K250212
- Device name
- LapBox Power Tissue Containment System
- Applicant
- Ark Surgical IL
- Product code
- PMU — Containment System, Laparoscopic Power Morcellation,
- Decision date
- 2025-04-15
- Date received
- 2025-01-24
- 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: K250212.pdf
Official FDA record: K250212
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.