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510(k) K192898

Device
PneumoLiner
Applicant
Advanced Surgical Concepts
510(k) number
K192898
Product code
PMU  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-25
Date received
2019-10-11
Regulation
884.4050
Classification name
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Edward Hyland
Address
Unit 4 Sunnybank Center, Upper Dargle Rd. Bray IE A98 E339 A98 E339

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PMU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250212LapBox Power Tissue Containment SystemArk Surgical2025-04-15
K212659More-Cell-SystemAgency For Medical Innovations GmbH2021-11-10
DEN150028PneumoLinerAdvanced Surgical Concepts, Ltd.2016-04-07

Legacy Summary#

summary

FDA Review#

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