FDA.report

LEEP PRECISION™ Smoke Evacuation System

Primary DI
00888937019940
Brand
LEEP PRECISION™ Smoke Evacuation System
Company
Coopersurgical, Inc.
Model
DM53502
Device description
LEEP PRECISION™ Smoke Evacuation System (120 VAC)
Published
2017-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K910377000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888937019940PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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