HIG

Insufflator, Hysteroscopic

Product code
HIG
Device name
Insufflator, Hysteroscopic
Device class
Class 2
21 CFR
21 CFR 884.1700
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
57 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-16.

NumberDecision dateApplicantDevice nameSummary
K2617062026-07-16KARL STORZ SE & CO. KGEndomat Select (UP220)PDF
K2512732026-03-27Boston Scientific CorporationAsurys Fluid Management SystemPDF
K2408862024-07-25Hologic, Inc.Fluent Pro Fluid Management System (FLT-200); Fluent…PDF

3 summaries are archived here for direct download.

Official FDA classification page: HIG
Classification and pathway per current FDA publications. Data from openFDA (CC0).