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FDA 510(k)

LapBox Tissue Containment Removal System

K-Number: K221365 · 2022-08-25

ApplicantArk Surgical, Ltd.
Decision Date2022-08-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LapBox Tissue Containment Removal System is a medical device manufactured by Ark Surgical, Ltd.. It received FDA 510(k) clearance on 2022-08-25 under approval number K221365. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LapBox Tissue Containment Removal System?

LapBox Tissue Containment Removal System is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Ark Surgical, Ltd.. The 510(k) number is K221365.

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

LapBox Tissue Containment Removal System received FDA 510(k) clearance on 2022-08-25, under approval number K221365.

What company makes LapBox Tissue Containment Removal System?

LapBox Tissue Containment Removal System is manufactured by Ark Surgical, Ltd..

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

The FDA product code for LapBox Tissue Containment Removal System is GCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

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Official Source

View on FDA Database →

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

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