FDA.reportPublic FDA data

NICO Myriad SPECTRA

Primary DI
00816744027476
Brand
NICO Myriad SPECTRA
Company
NICO CORPORATION
Model
NN-7047
Device description
Myriad SPECTRA Console
Published
2024-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K191599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191599000NICO Myriad NOVUSNico Corporation2019-09-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816744027476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816744027476008167440274768167440274760816744027476

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system control unitA mains electricity (AC-powered) component of a tissue morcellation system used to power and regulate the system's handpiece blade via cable connection; some designs may also provide suction intended for removal of resected tissue. This device will typically have hand and/or foot controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829838288
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816744028459NICO BrainPathNN-80452020-04-15
00816744021313NICO MyriadNN-13102025-07-30
00816744027230Myriad-LXNN-70232025-08-11
00816744020118NICO MyriadNN-11102025-07-30
00816744021139NICO MyriadNN-11132025-07-30
00816744021337NICO MyriadNN-13132025-07-30
00816744024031NICO MyriadNN-40032025-07-30
00816744024048NICO MyriadNN-40042025-07-30
00816744024062NICO MyriadNN-40062025-07-30
00816744024079NICO MyriadNN-40072025-07-30
00816744024178NICO MyriadNN-40172025-07-30
00816744024185NICO MyriadNN-40182025-07-30
00816744027131NICO Myriad-LXNN-70132019-09-30
00816744020095NICO MyriadNN-10012024-11-13
00816744020101NICO MyriadNN-10002024-11-13
00816744027728NICO Myriad SPECTRANN-70722024-06-07
00816744027704NICO Myriad NOVUSNN-70702023-04-28
00816744028244NICO BrainPathNN-80242016-09-14
00816744028251NICO BrainPathNN-80252016-09-14
00816744028268NICO BrainPathNN-80262016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14