PneumoLiner— 510(k) K192898

Clearance details

Applicant

Advanced Surgical Concepts

Product code

Code PMU

Device class

Class 2

Regulation

21 CFR 884.4050

Advisory panel

Obstetrics/Gynecology

Date received

2019-10-11

Decision date

2020-02-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bray, IE

• K250212 — LapBox Power Tissue Containment System2025-04-15
• K212659 — More-Cell-System2021-11-10
• DEN150028 — PneumoLiner2016-04-07

• K232701 — Guardenia (GAR-1)2023-09-29
• K121309 — ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE2012-09-06
• K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT2012-01-18
• K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE2011-01-26
• K101794 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA2010-11-29

• Z-0176-2022 — ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for 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.Class II·Terminated·Olympus Corporation of the Americas·20210921

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192898.