510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150028Unknown

PneumoLiner

Advanced Surgical Concepts, Bray, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN150028 is the FDA 510(k) clearance record for PneumoLiner, a class II device, cleared for Advanced Surgical Concepts, Ltd. on under FDA product code PMU (Containment System, Laparoscopic Power Morcellation, With Instrument Port). FDA's definition for product code PMU reads: "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...". FDA records list 12 510(k) clearances for Advanced Surgical Concepts, Ltd., from to . As of , FDA records show no recalls naming DEN150028.

Clearance record

Decision date
Received
(293 days to decision)
Product code
PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Regulation
21 CFR 884.4050
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Advanced Surgical Concepts, Ltd. Unit 4 Sunnybank Center, Upper Dargle Rd., Bray, IE
Third party review
No

Clearances, product code PMU

Trailing 12 months

FDA records hold no clearances under product code PMU in the trailing twelve months.

FDA records show no clearances under product code PMU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PMU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260