510(k) K250212
K250212 is an FDA 510(k) premarket notification submitted by Ark Surgical for the device "LapBox Power Tissue Containment System". The FDA issued a decision of Substantially Equivalent on April 15, 2025. The device falls under product code PMU (Containment System, Laparoscopic Power Morcellation, With Instrument Port), a Class II device regulated under 21 CFR 884.4050. Ark Surgical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2025
- Date Received
- January 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Containment System, Laparoscopic Power Morcellation, With Instrument Port
- Device Class
- Class II
- Regulation Number
- 884.4050
- Review Panel
- OB
- Submission Type
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.