FDA.reportPublic FDA data

Symphion 6.3 Hysteroscope

Primary DI
00850033976120
Brand
Symphion 6.3 Hysteroscope
Company
Minerva Surgical, Inc.
Model
FG-0703
Catalog number
FG-0703
Device description
Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller Contents:(1) Hysteroscope(1) Storz Scope Adapter(1) Wolf Scope Adapter(1) Working Channel Brush(1) Fluid Channel Brush
Published
2022-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729863670PreviousGS10
00850033976120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08714729863670087147298636708714729863670
00850033976120008500339761208500339761200850033976120

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
829616478
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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
00850033976335Symphion Operative Hysteroscopy System Prime ControllerFG-PRIME25FG-PRIME252025-10-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
10884521744080TruClearCovidien LPHIH2017-10-16
10884521744097TruClearCovidien LPHIH2017-10-16
10884521744103TruClearCovidien LPHIH2017-10-16
10884521744110TruClearCovidien LPHIH2017-10-16