FDA.reportPublic FDA data

FINESSE

Primary DI
H671FIN22200
Brand
FINESSE
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Finesse II+, 230VAC
Catalog number
FIN2-220
Device description
Electrosurgical Generator with Integrated Smoke Evacuation System, 230 VAC
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
HGIElectrocautery, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123310000FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)Utah Medical Products, Inc.2013-01-23GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671FIN22200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

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