FDA.reportPublic FDA data

Fluent Fluid Management System

Primary DI
25420045505275
Brand
Fluent Fluid Management System
Company
Hologic, Inc.
Model
FLT-010
Catalog number
FLT-010
Device description
The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIGInsufflator, hysteroscopic
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180825000Fluent Fluid Management SystemHologic, Inc.2018-08-03HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35420045505272PackageGS11In Commercial Distribution
45420045505279PackageGS14In Commercial Distribution
25420045505275PrimaryGS10
15420045505278Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3542004550527235420045505272
4542004550527945420045505279
2542004550527525420045505275
1542004550527815420045505278

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.

Contacts#

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

Regulatory Flags#

DUNS number
018925968
Device count
10
DM exempt
true
Lot or batch
true
Expiration date on label
true

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
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
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

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Primary DI, Brand, Company table
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07613327626407ThermaClearSTRYKER CORPORATIONHIG2025-04-04
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07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
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10884521744059NACovidien LPHIG2018-08-31
10884521744066NACovidien LPHIG2018-08-31
10884521744073NACovidien LPHIG2018-08-31
10884521744080TruClearCovidien LPHIH2017-10-16
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10884521744103TruClearCovidien LPHIH2017-10-16