LapBox Power Tissue Containment System

FDA 510(k) K250212 · Ark Surgical

Substantially Equivalent

510(k) numberK250212

Submission

Device name
LapBox Power Tissue Containment System
Applicant
Ark Surgical
13 Wadi El Haj, IL
Received
January 24, 2025
Decision date
April 15, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PMU – Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4050
Specialty
Obstetrics/Gynecology

Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are…

Other 510(k)s with product code PMU

510(k)DeviceApplicantDecision
K212659More-Cell-SystemPMU · Traditional Agency For Medical Innovations GmbH11/10/2021SE
K192898PneumoLinerPMU · Traditional Advanced Surgical Concepts02/25/2020SE

More from Advanced Surgical Concepts

510(k)DeviceDecision
K221365LapBox Tissue Containment Removal SystemGCJ · Traditional 08/25/2022SE

Questions and answers

When was LapBox Power Tissue Containment System cleared by the FDA?

LapBox Power Tissue Containment System (K250212) received a 510(k) decision of Substantially Equivalent on April 15, 2025, 81 days after the submission was received.

What is the product code of K250212?

The FDA product code is PMU – Containment System, Laparoscopic Power Morcellation, With Instrument Port, a Class II (moderate risk) device regulated under 21 CFR 884.4050.