FDA.reportPublic FDA data

Avecure

Primary DI
00858584002008
Brand
Avecure
Company
MEDWAVES, INC.
Model
14-15-LH-35
Catalog number
14-15-LH-35
Device description
14Gauge, Large Antenna Probe, 15cm length
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143203000AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-ProbeMedwaves Incorporated2015-08-26NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858584002008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858584002008008585840020088585840020080858584002008

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system probeA hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The probe includes a handle and an antenna, and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), and open surgery procedures to ablate tissues. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
122915353
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858584002022Avecure14-23-LH-3514-23-LH-352016-09-28
00858584002053Avecure16-15-LH-1516-15-LH-152016-09-28
00858584002077Avecure16-15-LH-1016-15-LH-102016-09-28
00858584002084AvecureMWG881MWG8812016-09-28
00858584002091Avecure14-20-LH-3514-20-LH-352016-09-28
00858584002114AvecureSECO, MECOSECO, MECO2016-09-28
00858584002138Avecure14-15-LH-2014-15-LH-202016-09-28
00858584002145Avecure14-23-LH-4R14-23-LH-4R2016-09-28
00858584002152Avecure16-10-LH-1516-10-LH-152016-09-28
00858584002169Avecure16-90-01-1516-90-01-152016-09-28
00858584002176Avecure16-158-01-1516-158-01-152016-09-28
00858584002183Avecure16-21-LH-1516-21-LH-152016-09-28
00858584002190Avecure14-30-LH-3514-30-LH-352016-09-28
00858584002206Avecure16-15-LH-3516-15-LH-352016-09-28
00858584002213Avecure14-20-LH-2014-20-LH-202016-09-28
00858584002220Avecure16-50-07-3516-50-07-352016-09-28

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