FDA.reportPublic FDA data

Electrode Handpiece, Hand Activated

Primary DI
GYNX755VL1
Brand
Electrode Handpiece, Hand Activated
Company
GYNEX CORPORATION
Model
755VL
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040780000ELECTROSURGICAL PENCILSHangzhou Shuyou Medical Instrument Company, Ltd.2005-02-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNX755VL1PrimaryHIBCC0
GYNX755VL0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system handpieceAn electrode handpiece that functions as the holder for a detachable cautery electrode, which together become the conducting unit, providing a means of conducting an electrical current used to heat the electrode tip used during surgical intervention to burn or sear body tissue. It will typically be made of heat and electrical resistant materials and include the cables/plugs that connect to the generator. This device can be used for, e.g., to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012997685
Device count
12
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

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Primary DI, Brand, Company table
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00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
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