FDA.reportPublic FDA data

Patient Dispersive Pad

Primary DI
GYNX60101
Brand
Patient Dispersive Pad
Company
GYNEX CORPORATION
Model
6010
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ODRElectrosurgical Patient Return Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODRElectrosurgical Patient Return ElectrodeGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091672000DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIESShuyou Electric Medical Science Co., Ltd.2009-12-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNX60101PrimaryHIBCC0
GYNX60100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-use, sterileA sterile dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012997685
Device count
12
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841494108434EXTRA-LARGE GROUNDING PADCynosure, LLCODR2020-01-31
10841494108431EXTRA-LARGE GROUNDING PAD, 25 PCSCynosure, LLCODR2020-01-31
B3702613910Cameron-MillerCAMERON-MILLER INCODR2017-02-11
00841494107130Neutral PadCynosure, LLCODR2017-01-30
GYNX218091Patient Dispercive PadGYNEX CORPORATIONODR2016-10-10
GYNX337141Patient Dispersive PadGYNEX CORPORATIONODR2016-10-10
00841645103974ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONODR2016-09-25
00841494103484IEC NEUTRAL PLATECynosure, LLCODR2016-09-21
00841494105167IEC NEUTRAL PADCynosure, LLCODR2016-09-21
00841494105273NEUTRAL PADCynosure, LLCODR2016-09-21