Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K251273

Asurys Fluid Management System

510(k) number
K251273
Device name
Asurys Fluid Management System
Applicant
Boston Scientific Corporation MA · US
Product code
HIG — Insufflator, Hysteroscopic
Decision date
2026-03-27
Date received
2025-04-24
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K251273.pdf

Official FDA record: K251273
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.