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510(k) K192898

PneumoLiner by Advanced Surgical Concepts — Product Code PMU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2020
Date Received
October 11, 2019
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.

Other clearances by Advanced Surgical Concepts

  • K232701 — Guardenia (GAR-1) (September 29, 2023)
  • K211234 — RedEx (September 17, 2021)
  • DEN170075 — ContainOR (December 19, 2017)
  • DEN150028 — PneumoLiner (April 7, 2016)
  • K121309 — ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (September 6, 2012)
  • K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (January 18, 2012)
  • K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (January 26, 2011)
  • K101794 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT (November 29, 2010)
  • K073719 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE (January 29, 2008)
  • K073170 — R-PORT II LAPAROSCOPIC ACCESS DEVICE (December 3, 2007)

Other clearances for product code PMU

  • K250212 — LapBox Power Tissue Containment System (April 15, 2025)
  • K212659 — More-Cell-System (November 10, 2021)
  • DEN150028 — PneumoLiner (April 7, 2016)