LapBox Power

GUDID 07290118830023

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.

ARK SURGICAL LTD

Tissue extraction bag

• Primary Device ID: 07290118830023
• NIH Device Record Key: a6aa5cf3-91fb-40c7-8e03-3f5ee6300d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LapBox Power
• Version Model Number: ARK-P01
• Company DUNS: 532362958
• Company Name: ARK SURGICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com
• Phone: +972523594441
• Email: stav@ark-surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290118830023 [Primary]
GS1	07290118830030 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250212

FDA Product Code

• PMU: Containment System, Laparoscopic Power Morcellation, With Instrument Port

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-25
• Device Publish Date: 2025-06-17