Cleared Traditional

LapBox Power Tissue Containment System

K250212 · Ark Surgical · Obstetrics & Gynecology
Apr 2025
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K250212 is an FDA 510(k) clearance for the LapBox Power Tissue Containment System, a Containment System, Laparoscopic Power Morcellation, With Instrument Port (Class II — Special Controls, product code PMU), submitted by Ark Surgical (13 Wadi El Haj, IL). The FDA issued a Cleared decision on April 15, 2025, 81 days after receiving the submission on January 24, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4050.

Submission Details

510(k) Number K250212 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2025
Decision Date April 15, 2025
Days to Decision 81 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PMU — Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4050
Definition 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 Between 15 Mm And 18 Mm In Shaft Outer Diameter And 135 Mm And 180 Mm In Shaft Working Length And Which Have An External Component That Allows For The Proper Orientation Of The Laparoscope To Perform A Contained Morcellation.