FDA.reportPublic FDA data

NEUWAVE

Primary DI
00818913020257
Brand
NEUWAVE
Company
NEUWAVE MEDICAL, INC.
Model
AC-UPGRADE
Catalog number
AC-UPGRADE
Device description
Upgrade to Certus 140-2.45GHz Ablation Confirmation
Published
2021-05-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, x-ray, tomography, computed
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192427000Ablation ConfirmationNeuwave Medical, Inc.2019-10-03JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818913020257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818913020257008189130202578189130202570818913020257

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system generatorA mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the liver, lung, pancreas and kidney.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-22 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Do not use if package is damaged

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)323-9283info@neuwave.com

Regulatory Flags#

DUNS number
809758878
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818913020698NEUWAVEPRS35PRS352024-06-14
20818913020695NEUWAVEPRS35PRS352024-06-14
00818913020509NEUWAVEPRS15PRS152020-12-08
00853719006494NEUWAVERC17PKRC17PK2017-04-13
00853719006951NEUWAVENWA1US1NNWA1US1N2017-11-03
00853719006968NEUWAVENWC1US1RNWC1US1R2018-08-26
00818913020677NEUWAVEDR-001446CTBKT52021-10-14
00818913020196NEUWAVENWF1US1NNWF1US1N2017-09-22
00853719006753NEUWAVENWC1US1NNWC1US1N2017-11-03
00818913020073NEUWAVENWF2HK1NNWF2HK1N2021-03-31
00818913020158NEUWAVENWF2SG1NNWF2SG1N2021-03-31
00818913020172NEUWAVENWF2CN1NNWF2CN1N2021-03-31
00818913020189NEUWAVEDR-000894DR-0008942021-03-31
00853719006005Certus® 1402.45 GHz Ablation SystemPR15cm - 17ga2016-09-18
00853719006012Certus® 1402.45 GHz Ablation SystemPR20cm - 17ga2016-09-18
00853719006029Certus® 1402.45 GHz Ablation SystemPR15cm - 15ga2016-09-18
00853719006036Certus® 1402.45 GHz Ablation SystemPR20cm - 15ga2016-09-18
00853719006043Certus® 1402.45 GHz Ablation SystemLK15cm - 17ga2016-09-18
00853719006050Certus® 1402.45 GHz Ablation SystemLK20cm - 17ga2016-09-18
00853719006067Certus® 1402.45 GHz Ablation SystemLK15cm - 15ga2016-09-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20