FDA 510(k)

PneumoLiner

K-Number: K192898 · 2020-02-25

Decision Date2020-02-25

Product CodePMU

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PneumoLiner is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts. It received FDA 510(k) clearance on 2020-02-25 under 510(k) 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. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K192898.

When did PneumoLiner receive FDA 510(k) clearance?

PneumoLiner received FDA 510(k) clearance on 2020-02-25, under 510(k) number K192898.

Who is the listed applicant for PneumoLiner?

The FDA 510(k) record lists Advanced Surgical Concepts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PneumoLiner?

The FDA product code for PneumoLiner is PMU.

Other records listing Advanced Surgical Concepts as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232701Guardenia (GAR-1)K211234RedEx

Related Devices (Code: PMU)

K250212LapBox Power Tissue Containment SystemArk Surgical K212659More-Cell-SystemAgency For Medical Innovations GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.