FDA.reportPublic FDA data

NovaSure

Primary DI
15420045514300
Brand
NovaSure
Company
Hologic, Inc.
Model
V5
Catalog number
NSV5KITUS-001
Device description
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Published
2021-07-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNBDevice, thermal ablation, endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNBDevice, Thermal Ablation, EndometrialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010013000
P010013081

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010013000NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMHologic, Inc.2001-09-28MNB
P010013081NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMHologic, Inc.2001-09-28MNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25420045514307PackageGS11In Commercial Distribution
35420045514304PackageGS13In Commercial Distribution
45420045514301PackageGS11In Commercial Distribution
15420045514300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2542004551430725420045514307
3542004551430435420045514304
4542004551430145420045514301
1542004551430015420045514300

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937026870Mara ConsoleCoopersurgical, Inc.MNB2024-03-13
00888937026887Mara Coopersurgical, Inc.MNB2023-12-01
00850044503018MinitouchMicrocube, LLCMNB2023-10-18
00850044503117MinitouchMicrocube, LLCMNB2023-10-18
00850044503124MinitouchMicrocube, LLCMNB2023-10-18
00850044503131MinitouchMicrocube, LLCMNB2023-10-18
00850044503148MinitouchMicrocube, LLCMNB2023-10-18
00850044503155MinitouchMicrocube, LLCMNB2023-10-18
00850044503162MinitouchMicrocube, LLCMNB2023-10-18
00850044503209MinitouchMicrocube, LLCMNB2023-10-18
10850044503015MinitouchMicrocube, LLCMNB2023-10-18
15420045515154NovaSureHologic, Inc.MNB2023-04-22
00850008595042Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2023-04-06
00850033976014Genesys HTA Control UnitMinerva Surgical, Inc.MNB2022-06-08
00850033976021Genesys HTA Control Unit - RefurbishedMinerva Surgical, Inc.MNB2022-06-08
00850033976038Genesys HTA ProCervaMinerva Surgical, Inc.MNB2022-06-08
15420045514294NovaSureHologic, Inc.MNB2021-07-02
25420045514307NovaSureHologic, Inc.MNB2021-07-02
00850008595028Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
20850008595022Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00850008595035Cerene Cryotherapy DeviceCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00857379006023Mara ConsoleAEGEA MEDICAL INC.MNB2020-03-16
00857379006030Mara Water Vapor Probe KitAEGEA MEDICAL INC.MNB2020-03-16
00862393000100Minerva RF ControllerMinerva Surgical, Inc.MNB2017-06-27
00862393000117Minerva Disposable HandpiecesMinerva Surgical, Inc.MNB2017-06-27
00862393000131Minerva Argon Gas Canister (5 pack)Minerva Surgical, Inc.MNB2017-06-27
00862393000148Minerva Co2 CanistersMinerva Surgical, Inc.MNB2017-06-27
00862393000155Minerva DesiccantMinerva Surgical, Inc.MNB2017-06-27
00862393000162Minerva Single Sterile Disposable HandpieceMinerva Surgical, Inc.MNB2017-06-27
00862393000179Minerva Hegar Dilator (3 Pack)Minerva Surgical, Inc.MNB2017-06-27