FDA.reportPublic FDA data

Apyx®

Primary DI
10607151049970
Brand
Apyx®
Company
APYX MEDICAL CORPORATION
Model
APYX-ESREC
Catalog number
APYX-ESREC
Device description
Disposable Split Adult Return Electrode with Cable
Published
2021-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K092761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092761000PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CBio Protech, Inc.2009-11-24GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151049970PrimaryGS10
00607151049973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715104997010607151049970
00607151049973006071510499736071510499730607151049973

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA 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 leads. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
101223287
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAYON-UAL-3726-32026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAYON-UAL-3733-12026-06-26
00607151051006AYON™ Power Liposuction Tubing AdaptorAYON-PL-ADPT2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAYON-PL-00012026-05-14
00607151057015AYON™ Power Liposuction CableAYON-PL-00022026-05-14
00607151050504AYON ConsoleAYON-CONSOLE2025-06-03
00607151050481AYON Wireless FootswitchAYON-FSW-00012025-05-29
00607151050498AYON Base TowerAYON-TOWER2025-05-29
00607151050511AYON Base Tower AYON-TOWER2025-05-29
00607151050528AYON Infiltration Handle AYON-IF-00012025-05-29
00607151050535AYON Infiltration Handle on/offAYON-IF-00022025-05-29
00607151050566AYON Ultrasound Assisted Liposuction Cable AYON-UAL-00022025-05-29
00607151050573AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 5 ringsAYON-UAL-3733-52025-05-29
00607151050580AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 5 ringsAYON-UAL-3726-52025-05-29
00607151050597AYON Ultrasound Assisted Liposuction Probe: 2.9mm diameter, 26cm length, 5 ringAYON-UAL-2926-52025-05-29
00607151050603AYON Ultrasound Assisted Liposuction Probe: 2.9mm diameter, 18cm length, 5 ringsAYON-UAL-2918-52025-05-29
00607151050610AYON Ultrasound Assisted Liposuction Probe: 2.2mm diameter, 18cm length, 3 ringsAYON-UAL-2218-32025-05-29
00607151050665AYON Skin Port Small 3mmAYON-SP-SMALL2025-05-29

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Primary DI, Brand, Company table
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
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