FDA.reportPublic FDA data

Acessa ProVu System

Primary DI
15420045515314
Brand
Acessa ProVu System
Company
Hologic, Inc.
Model
MS-06-0171
Catalog number
MS-06-0171
Device description
The Acessa ProVu Console Dual Foot Pedal
Published
2023-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFGCOAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045515314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551531415420045515314

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic navigation/ultrasound guided radio-frequency ablation system console/generatorAn electrically-powered, noninvasive unit designed to: 1) generate electrical energy in the radio-frequency (RF) band, for the focal RF ablation of soft tissues (e.g., uterine fibroids) via laparoscopic approach; 2) track the location of an electrosurgical ablation probe with respect to real-time ultrasound images; and 3) provide optional tracking and ultrasound image overlay based on electromagnetic (EM) guidance. It is intended to connect to an electrosurgical ablation probe/catheter (not included), a laparoscopic ultrasound transducer, an electromagnetic surgical navigation generator, and a monitor (not included) to target the RF delivery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11
15420045504585ATEC IntroducerAI120920AI1209202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045515260Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515277Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515291Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515246Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515253Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515307Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515284Acessa ProVu SystemHologic, Inc.HFG2022-11-08
00854763006256Acessa ProVu Dual Foot Pedal ACESSA HEALTH INC.HFG2020-12-07
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFG2020-07-31
00854763006102Acessa PadsACESSA HEALTH INC.HFG2018-10-11
00854763006119Acessa Pad CableACESSA HEALTH INC.HFG2018-10-11
00854763006126Acessa Table Top Field GeneratorACESSA HEALTH INC.HFG2018-10-11
00854763006140Acessa ProVu HandpieceACESSA HEALTH INC.HFG2018-10-11
00854763006157Acessa ProVu Handpiece CableACESSA HEALTH INC.HFG2018-10-11
00854763006188Acessa ProVu Transducer with sensorACESSA HEALTH INC.HFG2018-10-11
00854763006195Acessa ProVu Planar Field Generator (PFG)ACESSA HEALTH INC.HFG2018-10-11
00854763006232Acessa ProVu SystemACESSA HEALTH INC.HFG2018-10-11
00854763006249Acessa ProVu PFG Table ClampACESSA HEALTH INC.HFG2018-10-11
30653405009652CONMEDConmed CorporationHFG2016-09-24
30653405009669CONMEDConmed CorporationHFG2016-09-24
30653405009676CONMEDConmed CorporationHFG2016-09-24
30653405009683CONMEDConmed CorporationHFG2016-09-24
30653405009744CONMEDConmed CorporationHFG2016-09-24
30653405009768CONMEDConmed CorporationHFG2016-09-24
30653405009775CONMEDConmed CorporationHFG2016-09-24
30653405009782CONMEDConmed CorporationHFG2016-09-24
30653405009799CONMEDConmed CorporationHFG2016-09-24
30653405034449CONMEDConmed CorporationHFG2016-09-24
30653405034784NAConmed CorporationHFG2016-09-24
30653405034807CONMEDConmed CorporationHFG2016-09-24