FDA.reportPublic FDA data

Symphion Operative Hysteroscopy System Prime Controller

Primary DI
00850033976335
Brand
Symphion Operative Hysteroscopy System Prime Controller
Company
Minerva Surgical, Inc.
Model
FG-PRIME25
Catalog number
FG-PRIME25
Device description
Symphion Operative Hysteroscopy System Controller with Integrated Fluid ManagementContents:(1) Symphion Controller(1) Power Cord(1) Footswitch(1) Saline Pole
Published
2025-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIGInsufflator, Hysteroscopic
PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2
PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, BipolarObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033976090PreviousGS10
00850033976335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033976090008500339760908500339760900850033976090
00850033976335008500339763358500339763350850033976335

GMDN Terms#

Term, Definition table
TermDefinition
Electrolytic-plasma electrosurgical systemAn assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery.

Contacts#

Phone, Email table
PhoneEmail
855-646-7874customerservice@minervasurgical.com

Regulatory Flags#

DUNS number
829616478
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033976373HERizon Vista ViewPoint Endoscopic Video Image ProcessorJY-MIP-3000JY-MIP-30002026-04-01
00850033976380HERizon Vista Single Use Hysteroscope, DiagnosticSH-02ASH-02A2026-04-01
00850033976397HERizon Vista Single Use Hysteroscope, Model 2SH-02BSH-02B2026-04-01
00850033976403HERizon Vista Single Use Hysteroscope, PlusSH-04BSH-04B2026-04-01
00850033976410HERizon Vista Single Use Hysteroscope, ProSH-03C2026-04-01
00850033976359HERizon Disposable Endoscopic Scissors XLJY-JD-17-450-BJY-JD-17-450-B2026-02-13
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedFG-PRIME25-RFG-PRIME25-R2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLJY-JD-17-450-BJY-JD-17-450-B2026-02-13
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLJY-CC-450-18-SJY-CC-450-18-S2026-02-12
00850033976298HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-SJY-CC-350-18-S2024-10-07
00850033976311HERizon Disposable Endoscopic ScissorsJY-JD-17-350-BJY-JD-17-350-B2024-10-07
00850033976267HERizon Disposable Electronic HysteroscopeJY-DEH-001JY-DEH-0012024-10-07
00850033976274HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
00850033976281HERizon Disposable Endoscopic Forceps - Foreign Body GrasperJY-C-350-18-SJY-C-350-18-S2024-10-07
00850033976304HERizon Disposable Endoscopic Forceps - Inverted ToothJY-DC-350-18-SJY-DC-350-18-S2024-10-07
00850033976250HERizon Medical Endoscope Image Processor JY-MIP-1000JY-MIP-10002024-10-07
10850033976264HERizon Disposable Electronic HysteroscopeJY-DEH-001JY-DEH-0012024-10-07
10850033976271HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
10850033976288HERizon Disposable Endoscopic Forceps - Foreign Body GrasperJY-C-350-18-SJY-C-350-18-S2024-10-07
10850033976295HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-SJY-CC-350-18-S2024-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506023348Asurys™BOSTON SCIENTIFIC CORPORATIONHIG2026-04-03
00191506047962Asurys™BOSTON SCIENTIFIC CORPORATIONHIG2026-04-03
00850006759835Aveta Tissue Catch with TubingMEDITRINA, INC.HIG2026-03-20
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedMinerva Surgical, Inc.PGT2026-02-13
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedMinerva Surgical, Inc.HIG2026-02-13
03700111401099RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401105RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401112RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401129RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
03700111401136SLIDING RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401143SLIDING RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401150SLIDING RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401167SLIDING RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
00850006759811Aveta Drape PumpMEDITRINA, INC.HIG2025-04-11
07613327626391ThermaClearSTRYKER CORPORATIONHIG2025-04-04
07613327626407ThermaClearSTRYKER CORPORATIONHIG2025-04-04
04048551377567NAKarl Storz GmbH & Co. KGHIG2025-03-27
00821925002630Gyrus ACMIGyrus ACMI, LLCHIG2024-12-09
25420045516110Fluent Pro Waste BagHologic, Inc.HIG2024-10-15
25420045516134Fluent Pro Tissue TrapHologic, Inc.HIG2024-10-15
15420045516144Fluent Pro Procedure KitHologic, Inc.HIG2024-10-15
00850006759699Aveta Waste Management AccessoryMEDITRINA, INC.HIG2024-10-14
00850006759736Aveta Waste Bag with Tissue CatchMEDITRINA, INC.HIG2024-10-14
00850033976236INFINITY Fluid Management AccessoryMinerva Surgical, Inc.PGT2024-08-12
00850033976243Symphion Fluid Deficit ReadoutMinerva Surgical, Inc.PGT2024-08-12
00850033976243Symphion Fluid Deficit ReadoutMinerva Surgical, Inc.HIG2024-08-12
15420045516212Fluent Pro Fluid Management SystemHologic, Inc.HIG2024-08-06
04056702012861GYN-PumpW.O.M. World of Medicine GmbHHIG2024-06-28
04056702012878Fluid Monitoring UnitW.O.M. World of Medicine GmbHHIG2024-06-28
00850006759460Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26