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510(k) K250212

Device
LapBox Power Tissue Containment System
Applicant
Ark Surgical
510(k) number
K250212
Product code
PMU
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-15
Date received
2025-01-24
Regulation
884.4050
Classification name
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stav Tori
Address
13 Wadi El Haj 13 Wadi El Haj IL 1603611 1603611

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PMU#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212659More-Cell-SystemAgency For Medical Innovations GmbH2021-11-10
K192898PneumoLinerAdvanced Surgical Concepts2020-02-25
DEN150028PneumoLinerAdvanced Surgical Concepts, Ltd.2016-04-07