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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 a medical device manufactured by Minerva Surgical, Inc.. It received FDA 510(k) clearance on 2024-01-17 under approval 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. It is manufactured by Minerva Surgical, Inc.. The 510(k) number is K233710.

When was Symphion Operative Hysteroscopy System approved by the FDA?

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

What company makes Symphion Operative Hysteroscopy System?

Symphion Operative Hysteroscopy System is manufactured by Minerva Surgical, Inc..

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

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

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Official Source

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

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