FDA.reportPublic FDA data

Endosee

Primary DI
00888937022452
Brand
Endosee
Company
Coopersurgical, Inc.
Model
OR-ES8000
Device description
Hysteroscope/Cystoscope, Charging Station, USB cable, and power cord
Published
2018-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170660000Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.2017-07-13HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937022452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937022452008889370224528889370224520888937022452

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video hysteroscopeAn endoscope with a flexible 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 a video system with a charge-coupled device (CCD) chip at the distal end of the endosocpe and the images showing on a monitor. Distention of the uterus with, e.g., carbon dioxide (CO2) gas may be used to improve viewing. It 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327055306NASTRYKER CORPORATIONFAJ2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055313NASTRYKER CORPORATIONFAJ2016-09-23
07613327055320NASTRYKER CORPORATIONFAJ2016-09-23
07613327055337NASTRYKER CORPORATIONFAJ2016-09-23
07613327055344NASTRYKER CORPORATIONFAJ2016-09-23
07613327055351NASTRYKER CORPORATIONFAJ2016-09-23
07613327055368NASTRYKER CORPORATIONFAJ2016-09-23
07613327055375NASTRYKER CORPORATIONFAJ2016-09-23
07613327055382NASTRYKER CORPORATIONFAJ2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAJ2016-09-23
07613327055405NASTRYKER CORPORATIONFAJ2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055412NASTRYKER CORPORATIONFAJ2016-09-23
07613327055429NASTRYKER CORPORATIONFAJ2016-09-23
07613327055436NASTRYKER CORPORATIONFAJ2016-09-23
07613327055443NASTRYKER CORPORATIONFAJ2016-09-23
07613327055450NASTRYKER CORPORATIONFAJ2016-09-23
07613327055467NASTRYKER CORPORATIONFAJ2016-09-23
07613327055474NASTRYKER CORPORATIONFAJ2016-09-23
07613327055481NASTRYKER CORPORATIONFAJ2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAJ2016-09-23
07613327055504NASTRYKER CORPORATIONFAJ2016-09-23
07613327055511NASTRYKER CORPORATIONFAJ2016-09-23
07613327055528NASTRYKER CORPORATIONFAJ2016-09-23
07613327055535NASTRYKER CORPORATIONFAJ2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAJ2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23