Symphion Operative Hysteroscopy System— 510(k) K233710

Name: FDA 510(k) clearance K233710
Creator: U.S. Food and Drug Administration
Published: 2024-01-17

Substantially Equivalent

Minerva Surgical, Inc.

FDA 510(k) clearance K233710 for Symphion Operative Hysteroscopy System, Substantially Equivalent on 2024-01-17. Applicant: Minerva Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Minerva Surgical, Inc.
Product code: Code PGT
Device class: Class 2
Regulation: 21 CFR 884.1710
Advisory panel: Obstetrics/Gynecology
Date received: 2023-11-20
Decision date: 2024-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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