Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Ark Surgical, Ltd.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) 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. The listed applicant is Ark Surgical, Ltd.. The 510(k) number is K221365.

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

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

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

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

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

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

Other records listing Ark Surgical, Ltd. 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.

K250212LapBox Power Tissue Containment System

Related Devices (Code: GCJ)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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.

↑