K240886

Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

510(k) number: K240886
Device name: Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
Applicant: Hologic, Inc. MA · US
Product code: HIG — Insufflator, Hysteroscopic
Decision date: 2024-07-25
Date received: 2024-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K240886.pdf

Official FDA record: K240886

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.