FDA.reportPublic FDA data

XenoBox

Primary DI
00854490007021
Brand
XenoBox
Company
XENOCOR, INC.
Model
XD-A1
Catalog number
XD-A1
Device description
aka Xenoscope Dongle.Video Processing Unit (VPU)
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161838000
K171344000
K193315000
K220872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161838000Xenocor Xenoscope Laparoscopic SystemXenocor, Inc.2016-09-26GCJ
K171344000Xenocor Xenoscope Laparoscopic SystemXenocor, Inc.2017-06-01GCJ
K193315000Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc.2020-01-27GCJ
K220872000Saberscope5 LaparoscopeXenocor, Inc.2022-04-20GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854490007021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854490007021008544900070218544900070210854490007021

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080306345
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854490007045Saberscope™ Articulating LaparoscopeSAS-A-536LSAS-A-536L2026-04-20
00854490007052Saberscope™ Video Processing UnitVPUX-1VPUX-12026-04-20
00854490007007Xenoscope 0°XS-0-1036XS-0-10362024-12-17
00854490007014Xenoscope 30°XS-30-1036XS-30-10362024-12-17
00854490007038SaberscopeXSA-0-0536XSA-0-05362024-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
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