LapBox Power Tissue Containment System— 510(k) K250212

Name: FDA 510(k) clearance K250212
Creator: U.S. Food and Drug Administration
Published: 2025-04-15

Substantially Equivalent

Ark Surgical

FDA 510(k) clearance K250212 for LapBox Power Tissue Containment System, Substantially Equivalent on 2025-04-15. Applicant: Ark Surgical. Device class: 2.

Clearance details

Applicant: Ark Surgical
Product code: Code PMU
Device class: Class 2
Regulation: 21 CFR 884.4050
Advisory panel: Obstetrics/Gynecology
Date received: 2025-01-24
Decision date: 2025-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 13 Wadi El Haj, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.