Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Symphion Operative Hysteroscopy System

K-Number: K233710 · 2024-01-17

ApplicantMinerva Surgical, Inc.
Decision Date2024-01-17
Product CodePGT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Symphion Operative Hysteroscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Minerva Surgical, Inc.. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233710. The device is classified under product code PGT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symphion Operative Hysteroscopy System?

Symphion Operative Hysteroscopy System is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Minerva Surgical, Inc.. The 510(k) number is K233710.

When did Symphion Operative Hysteroscopy System receive FDA 510(k) clearance?

Symphion Operative Hysteroscopy System received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233710.

Who is the listed applicant for Symphion Operative Hysteroscopy System?

The FDA 510(k) record lists Minerva Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symphion Operative Hysteroscopy System?

The FDA product code for Symphion Operative Hysteroscopy System is PGT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑