FDA.reportPublic FDA data

Surgical plume evacuation system

Definition
A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube
GUDID devices
381
Last updated
2026-09-29 04:00:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10840113242785BovieASPEN SURGICAL PRODUCTS, INC.SEPAT2026-09-18
10840113242792BovieASPEN SURGICAL PRODUCTS, INC.SEPA2026-09-18
00850043007067SAFE® System Surgical Smoke EvacuatorHydrafacial LLC100002016-09-20
10607151008298BovieASPEN SURGICAL PRODUCTS, INC.SE022016-09-16
10607151008304BovieASPEN SURGICAL PRODUCTS, INC.SE02-2202016-09-16
10607151008496BovieASPEN SURGICAL PRODUCTS, INC.SERS22016-09-16
10607151065161BovieASPEN SURGICAL PRODUCTS, INC.SEAS2016-09-16
10705036046523MegadyneETHICON ENDO-SURGERY, LLC2255JTES2026-05-27
00749756157858DeRoyalDEROYAL INDUSTRIES, INC.88-0007022016-09-12
00749756157865DeRoyalDEROYAL INDUSTRIES, INC.88-0006022016-09-12
00749756157889DeRoyalDEROYAL INDUSTRIES, INC.88-0006002016-09-12
00749756157919DeRoyalDEROYAL INDUSTRIES, INC.88-0007222016-09-12
00749756157926DeRoyalDEROYAL INDUSTRIES, INC.88-0006222016-09-12
00749756157933DeRoyalDEROYAL INDUSTRIES, INC.88-0006212016-09-12
00749756157964DeRoyalDEROYAL INDUSTRIES, INC.88-0035902016-09-12
00749756157971DeRoyalDEROYAL INDUSTRIES, INC.88-0035402016-09-12
00749756231176DeRoyalDEROYAL INDUSTRIES, INC.88-0006952016-09-12
00749756231206DeRoyalDEROYAL INDUSTRIES, INC.88-00M7022016-09-12
00749756231251DeRoyalDEROYAL INDUSTRIES, INC.88-3590NS2016-09-12
00749756231268DeRoyalDEROYAL INDUSTRIES, INC.88-722NS2016-09-12
00749756236003DeRoyalDEROYAL INDUSTRIES, INC.88-0007232016-09-12
00749756237482DeRoyalDEROYAL INDUSTRIES, INC.88-0007032016-09-12
00749756237499DeRoyalDEROYAL INDUSTRIES, INC.88-0006962021-07-12
00749756248112DeRoyalDEROYAL INDUSTRIES, INC.88-0157222016-09-12
00749756248129DeRoyalDEROYAL INDUSTRIES, INC.88-600NS2016-09-12
00749756248662DeRoyalDEROYAL INDUSTRIES, INC.88-702NS2016-09-12
00749756305655DeRoyalDEROYAL INDUSTRIES, INC.88-0007002016-09-12
00749756314763DeRoyalDEROYAL INDUSTRIES, INC.88-0007252016-09-12
00749756872584DeRoyalDEROYAL INDUSTRIES, INC.88-000722NS2016-09-12
00749756874335DeRoyalDEROYAL INDUSTRIES, INC.88-000725NS2016-09-12
00749756874359DeRoyalDEROYAL INDUSTRIES, INC.88-000702NS2016-09-12
00749756874366DeRoyalDEROYAL INDUSTRIES, INC.88-00M702NS2016-09-12
00749756876148DeRoyalDEROYAL INDUSTRIES, INC.88-000723NS2016-09-12
00749756877008DeRoyalDEROYAL INDUSTRIES, INC.88-000601NS2016-09-12
00749756884051DeRoyalDEROYAL INDUSTRIES, INC.88-003590NS2016-09-12
00817325020749MediMax TechMEDIMAX TECH INC.EvBN Push Button ESU Pencil2016-08-09
00817325020763MediMax TechMEDIMAX TECH INC.EvBNH Push Button ESU Smoke Pencil2016-08-09
00817325022972MediMax TechMEDIMAX TECH INC.EvBNH-102018-05-25
00817325022989MediMax TechMEDIMAX TECH INC.EvBNH-152018-05-25
00817325022996MediMax TechMEDIMAX TECH INC.EvBNHT-102018-05-25
00817325023009MediMax TechMEDIMAX TECH INC.EvBNHT-152018-05-25
00817325023016MediMax TechMEDIMAX TECH INC.EcoEvBNH-102018-05-25
00817325023023MediMax TechMEDIMAX TECH INC.EcoEvBNH-152018-05-25
00817325023030MediMax TechMEDIMAX TECH INC.EcoEvBNHT-10 2018-05-25
00817325023047MediMax TechMEDIMAX TECH INC.EcoEvBNHT-152018-05-25
00817325023054MediMax TechMEDIMAX TECH INC.EcoEvRNH-102018-05-31
00817325023061MediMax TechMEDIMAX TECH INC.EcoEvRNH-152018-05-25
00817325023078MediMax TechMEDIMAX TECH INC.EcoEvRNHT-10 2018-05-25
00817325023085MediMax TechMEDIMAX TECH INC.EcoEvRNHT-152018-05-25
00817325023412MediMax TechMEDIMAX TECH INC.SPST2019-02-12
00817325023436MediMax TechMEDIMAX TECH INC.SPSTI2019-02-21
00817325023450MediMax TechMEDIMAX TECH INC.SPDE2019-02-12
00817325023474MediMax TechMEDIMAX TECH INC.SPDEI2019-02-21
00817325023528MediMax TechMEDIMAX TECH INC.SPECI2019-02-21
00817325023573MediMax TechMEDIMAX TECH INC.EQM-CAF2019-09-03
00817325023580MediMax TechMEDIMAX TECH INC.FIT2019-09-03
00817325023597MediMax TechMEDIMAX TECH INC.FIT-52019-09-03
00817325023634MediMax TechMEDIMAX TECH INC.SPDE-SL52019-12-02
00817325023658MediMax TechMEDIMAX TECH INC.SPDEI-SL52019-12-02
00817325023689MediMax TechMEDIMAX TECH INC.SPEC-SL52019-12-02
00817325023702MediMax TechMEDIMAX TECH INC.SPECI-SL52019-12-02
00817325023726MediMax TechMEDIMAX TECH INC.SPST-SL52019-12-02
00817325023740MediMax TechMEDIMAX TECH INC.SPSTI-SL52019-12-02
00817688021438ULPA Filter & Water TrapI.C. MEDICAL, INC.ICM-000-00142016-09-24
00817688021452ULPA Filter & Water TrapI.C. MEDICAL, INC.ICM-000-03072016-09-24
00817688021476ULPA Filter & Water TrapI.C. MEDICAL, INC.22102016-09-24
00817688021490Opaque ULPA Filter & Water TrapI.C. MEDICAL, INC.ICM-000-04342016-09-24
00817688021636ULPA Box FilterI.C. MEDICAL, INC.ICM-000-02622016-09-24
00817688021650ULPA Box FilterI.C. MEDICAL, INC.ICM-000-02762016-09-24
00817688021674ULPA Box FilterI.C. MEDICAL, INC.ICM-000-02892016-09-24
00817688021773ULPA Box FilterI.C. MEDICAL, INC.ICM-000-04602016-09-24
00817688022343NAI.C. MEDICAL, INC.2210J2017-09-15
00817688022992STERISI.C. MEDICAL, INC.SSEFIL012021-10-19
00842071139346Remora Smoke and Fluid Evacuation SystemAPPLIED MEDICAL TECHNOLOGY, INC.EST90002024-11-22
00842071139353Remora Smoke and Fluid Evacuation SystemAPPLIED MEDICAL TECHNOLOGY, INC.EST91002024-11-22
00850034735122MediSourceNet, IncMedisourcenet, IncWELF2021-08-30
00850034735139MediSourceNet, IncMedisourcenet, IncWELF-52021-08-30
00872320005504Aegis Aerosol VacStation Primary FilterCAO GROUP, INC.005-000462020-04-29
00872320005603Aegis Aerosol VacStation Small Inlet CollectorCAO GROUP, INC.005-000862020-05-21
00872320005696Aegis Air Filtration SystemCAO GROUP, INC.005-000872020-06-10