PneumoLiner
K-Number: K192898 · 2020-02-25
ApplicantAdvanced Surgical Concepts
Decision Date2020-02-25
Product CodePMU
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
PneumoLiner is a medical device manufactured by Advanced Surgical Concepts. It received FDA 510(k) clearance on 2020-02-25 under approval number K192898. The device is classified under product code PMU. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PneumoLiner?
PneumoLiner is a medical device that received FDA 510(k) clearance on 2020-02-25. It is manufactured by Advanced Surgical Concepts. The 510(k) number is K192898.
When was PneumoLiner approved by the FDA?
PneumoLiner received FDA 510(k) clearance on 2020-02-25, under approval number K192898.
What company makes PneumoLiner?
PneumoLiner is manufactured by Advanced Surgical Concepts.
What is the FDA product code for PneumoLiner?
The FDA product code for PneumoLiner is PMU.
Other Devices by Advanced Surgical Concepts
Related Devices (Code: PMU)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.