FDA.reportPublic FDA data

LEEP System 1000® Smoke Evacuation System

Primary DI
00888937014440
Brand
LEEP System 1000® Smoke Evacuation System
Company
Coopersurgical, Inc.
Model
6080-2
Device description
LEEP System 1000® Smoke Evacuation System (110 VAC)
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910377000COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEMCooperSurgical, Inc.1991-04-19GCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937014440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937014440008889370144408889370144400888937014440

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956534681CARDINAL HEALTHCardinal Health 200, LLCGCX2026-07-27
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
00848530084011Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-06-18
00848530099640Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCX2025-05-21
00848530103996Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-14
00848530104009Oxygen Wrench and Washer KitSunset Healthcare Solutions, Inc.GCX2025-05-14
00848530105464Washer with Rubber Ring - AluminumSunset Healthcare Solutions, Inc.GCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
00848530105747Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105754Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105723Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105730Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08
08682952417437DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417451DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417482DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
10192253041736ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041743ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041750ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253038965ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038972ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038989ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038996ArgyleCardinal Health 200, LLCGCX2025-02-28