Flamingo Funnel (miniSQUAIR) - Large

Primary DI
10860012888808
Brand
Flamingo Funnel (miniSQUAIR) - Large
Company
NASCENT SURGICAL, LLC
Model
SQ20012-01
Device description
"The Device is an end-piece smoke collector to be used as an alternative to the standard plastic ""wand"" smoke collector in current use with smoke evacuation Systems for laser surgical procedures (Smoke evacuation system, Laser; classification number, 79VCN; docket: none). Specifically, the Device is an end-piece smoke collector to be attached to laser plume evacuation systems currently in use. The Device is used by attaching it to the same type of sterile hose to which the wand-type smoke collector is attached, as currently used in laser plume evacuation Systems. The Device is disposed of after each use. The Device is manufactured in three sizes, all of which have the same function and intended use."
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894038000PLUME-AWAY SMOKE EVACUATION SYSTEMLaser Technologies Group, Inc.1989-09-28FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860012888808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086001288880810860012888808

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system filterA screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).

Contacts#

Phone, Email table
PhoneEmail
952-345-1112info@surgismokesolutions.com

Regulatory Flags#

DUNS number
047059499
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198715154716SurgiSmoke Solutions Non-Sterile Extension TubingSQ20012-042026-05-01
10860012888815Flamingo Funnel (microSQUAIR) - MediumSQ20012-022026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small SQ20012-032026-05-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
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