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FDA 510(k)

LapBox Power Tissue Containment System

K-Number: K250212 · 2025-04-15

ApplicantArk Surgical
Decision Date2025-04-15
Product CodePMU
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LapBox Power Tissue Containment System is a medical device manufactured by Ark Surgical. It received FDA 510(k) clearance on 2025-04-15 under approval number K250212. The device is classified under product code PMU. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LapBox Power Tissue Containment System?

LapBox Power Tissue Containment System is a medical device that received FDA 510(k) clearance on 2025-04-15. It is manufactured by Ark Surgical. The 510(k) number is K250212.

When was LapBox Power Tissue Containment System approved by the FDA?

LapBox Power Tissue Containment System received FDA 510(k) clearance on 2025-04-15, under approval number K250212.

What company makes LapBox Power Tissue Containment System?

LapBox Power Tissue Containment System is manufactured by Ark Surgical.

What is the FDA product code for LapBox Power Tissue Containment System?

The FDA product code for LapBox Power Tissue Containment System is PMU.

Related Clinical Trials

Related PubMed Literature

Related Devices (Code: PMU)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.