FDA 510(k)

LapBox Power Tissue Containment System

K-Number: K250212 · 2025-04-15

Decision Date2025-04-15

Product CodePMU

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LapBox Power Tissue Containment System is the device name listed in this FDA 510(k) record. The listed applicant is Ark Surgical. It received FDA 510(k) clearance on 2025-04-15 under 510(k) 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. The listed applicant is Ark Surgical. The 510(k) number is K250212.

When did LapBox Power Tissue Containment System receive FDA 510(k) clearance?

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

Who is the listed applicant for LapBox Power Tissue Containment System?

The FDA 510(k) record lists Ark Surgical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ark Surgical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221365LapBox Tissue Containment Removal System

Related Devices (Code: PMU)

K212659More-Cell-SystemAgency For Medical Innovations GmbH K192898PneumoLinerAdvanced Surgical Concepts

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.