meddevicedb.com FDA Device Reference

PneumoLiner

DEN150028 Class II Direct
Decision Date
2016-04-07
Sponsor / Applicant
Advanced Surgical Concepts, Ltd.

Technical Specification

510(k) Submission ID DEN150028
Product Code PMU
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.4050
Decision Date 2016-04-07
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PneumoLiner received FDA 510(k) clearance under submission number DEN150028, sponsored by Advanced Surgical Concepts, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2016-04-07.

Classification & Regulation

This clearance is catalogued under FDA product code PMU and 21 CFR 884.4050, within the Obstetrics/Gynecology review panel as a Class II device.