Symphion Fluid Deficit Readout

FDA UDI

Class II (US FDA UDI)

by Minerva Surgical, Inc.

Identity

Trade Name: Symphion Fluid Deficit Readout FDA UDI
Generic Name: Electrolytic-plasma electrosurgical system FDA UDI
Device Name: Symphion Operative Hysteroscopy System Fluid Deficit Readout For use with Symphion Controller SW Version 3.0.0 or higher. Contents: (1) Display Controller (2) Power Supply (3) Power Cord FDA UDI
Model / Reference: FG-FDR1 FDA UDI
Description: Symphion Operative Hysteroscopy System Fluid Deficit Readout For use with Symphion Controller SW Version 3.0.0 or higher. Contents: (1) Display Controller (2) Power Supply (3) Power Cord FDA UDI

Identifiers

Catalog Number: FG-FDR1 FDA UDI
Primary DI / UDI-DI: 00850033976243 FDA UDI
FDA Product Code: PGT FDA UDI
HIG FDA UDI
GMDN Term: Electrolytic-plasma electrosurgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1710 FDA UDI
884.1700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrolytic-plasma electrosurgical system

Symphion Fluid Deficit Readout by Minerva Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electrolytic-plasma electrosurgical system.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Minerva Surgical, Inc.

Sources (1)

FDA UDI a2e93166-2cec-4610-a48e-9407ef4a25d8 35 fields · synced May 30, 2026