LapBox Power

ARK SURGICAL LTD · Model ARK-P01 · UDI-DI 07290118830023

PMU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

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.

Recalls

Date	Firm	Reason
2021-09-21	Olympus Corporation of the Americas	Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, whic

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.