FDA.reportPublic FDA data

510(k) K213068

Device
Medline Smoke Evacuation Shroud
Applicant
Medline Industries, Inc.
510(k) number
K213068
Product code
FYD
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-03
Date received
2021-09-23
Regulation
878.5070
Classification name
Apparatus, Exhaust, Surgical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Matt Clausen
Address
Three Lakes Dr. Northfiled IL US 60093 60093

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FYD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240127PlumeSafe X5 Smoke Management SystemConmed Corporation2024-08-05
K2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation2024-04-10
K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.2021-03-25
K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.2020-06-26
K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.2019-08-29
K191328Megadyne Foot SwitchMegadyne Medical Products, Inc.2019-07-26
K182224SafeAir Smoke Evacuator compactLina Medical Aps2019-02-07
K173108SmokleanSejong Medical Co., Ltd.2018-05-18
K163659Crystal VisionI.C Medical, Inc.2017-10-30
K142335RapidVac Smoke Evacuator SystemCovidien2015-01-14
K131402VISICLEAR SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.2014-03-03
K091139CONMED AER DEFENSE SMOKE EVACUATORConmed Corporation2009-05-05
K053464SERVICE MANAGER SM40SEConmed Integrated Systems, Canada, Ulc2006-06-06
K052797LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUMMedtek Devices, Inc.2006-02-13
K043494MASTEL LASER CLEAN ROOM, MODEL EBS-100Mastel Precision Surgical Instruments, Inc.2005-10-04