LapBox Power

Primary DI
07290118830023
Brand
LapBox Power
Company
ARK SURGICAL LTD
Model
ARK-P01
Device description
The LapBox Power Contained Tissue Extraction System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be power morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMUContainment System, Laparoscopic Power Morcellation, With Instrument PortObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250212000LapBox Power Tissue Containment SystemArk Surgical2025-04-15PMU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290118830030PackageGS15In Commercial Distribution
07290118830023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290118830030072901188300307290118830030
07290118830023072901188300237290118830023

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972523594441stav@ark-surgical.com

Regulatory Flags#

DUNS number
532362958
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290118830009LapBox Tissue Containment Removal SystemARK-M012022-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EAMIMCS55310More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55510More-Cell-System 30AMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55110More-Cell-SystemAMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55311More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
MCS55511More-Cell-System 30AMI Agency for Medical Innovations GmbHPMU2021-12-09
05391530440004PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19
05391530440011PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19