FDA.reportPublic FDA data

Minerva RF Controller

Primary DI
00862393000100
Brand
Minerva RF Controller
Company
Minerva Surgical, Inc.
Model
MIN180S
Catalog number
MIN180S
Device description
MINERVA RF ControllerContents:(1) One MINERVA RF-Controller(1) One Footswitch(1) One Power Cord
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNBDevice, Thermal Ablation, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNBDevice, Thermal Ablation, EndometrialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140013012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140013012MINERVA ENDOMETRIAL ABLATION SYSTEMAxora Medical, Inc.2015-07-27MNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862393000100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862393000100008623930001008623930001000862393000100

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced endoscopic electrosurgical submucosal lift/resection instrumentA flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of argon (Ar) gas (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by argon plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to the appropriate parent devices (i.e., argon-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include any controls. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-284-3500klydek@minervasurgical.com
855-646-7874customerservice@minervasurgical.co
855-646-7874customerservice@minervasurgical.com

Regulatory Flags#

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

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00850033976403HERizon Vista Single Use Hysteroscope, PlusSH-04BSH-04B2026-04-01
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00850033976304HERizon Disposable Endoscopic Forceps - Inverted ToothJY-DC-350-18-SJY-DC-350-18-S2024-10-07
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10850033976271HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
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Primary DI, Brand, Company table
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