Symphion Controller - Refurbished

FDA UDI

Class II (US FDA UDI)

by Minerva Surgical, Inc.

Identity

Trade Name: Symphion Controller - Refurbished FDA UDI
Generic Name: Electrolytic-plasma electrosurgical system FDA UDI
Device Name: Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management - Refurbished Contents: (1) Symphion Controller (1) Power Cord (1) Footswitch (1) Saline Pole FDA UDI
Model / Reference: FG-0612-R FDA UDI
Description: Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management - Refurbished Contents: (1) Symphion Controller (1) Power Cord (1) Footswitch (1) Saline Pole FDA UDI

Identifiers

Catalog Number: FG-0612-R FDA UDI
Primary DI / UDI-DI: 00850033976106 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

Yes

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 Controller - Refurbished by Minerva Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrolytic-plasma electrosurgical system.

BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Minerva Surgical, Inc.

Sources (1)

FDA UDI f4cbc77c-fba9-4da7-b1c1-6fe4b77ced96 35 fields · synced Jun 8, 2026