Identity
- Trade Name
- Symphion Controller FDA UDI
- Generic Name
- Electrolytic-plasma electrosurgical system FDA UDI
- Device Name
- Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Contents: (1) Symphion Controller (1) Power Cord (1) Footswitch (1) Saline Pole FDA UDI
- Model / Reference
- FG-0612 FDA UDI
- Description
- Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Contents: (1) Symphion Controller (1) Power Cord (1) Footswitch (1) Saline Pole FDA UDI
Identifiers
- Catalog Number
- FG-0612 FDA UDI
- Primary DI / UDI-DI
- 00850033976090 FDA UDI
- FDA Product Code
- PGT FDA UDIHIG FDA UDI
- GMDN Term
- Electrolytic-plasma electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1710 FDA UDI884.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrolytic-plasma electrosurgical system
Symphion Controller by Minerva Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 fd584ad3-8849-4f92-965a-700fa0b7674b 35 fields · synced May 29, 2026