FDA.reportPublic FDA data

KLYO

Primary DI
B773KMOPT0
Brand
KLYO
Company
KLYO MEDICAL SYSTEMS INC.
Model
KMOPT
Device description
Mobile, operating tables (Mechanical Operating Tables, Hydraulic Operating Tables) designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions to satisfy the requirements of many clinical specialties.
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWXTable, Operating-Room, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWXTable, Operating-Room, MechanicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B773KMOPT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table, hydraulicA mobile, manually-operated hydraulic table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface) to satisfy the requirements of many clinical specialties. It is typically operated via an integral foot-pedal(s) that adjust the table top position.

Contacts#

Phone, Email table
PhoneEmail
3053305025sales@klyomedical.com

Regulatory Flags#

DUNS number
058639417
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B773KEHBD0KLYOKEHBD2024-02-23
B773KHSTR0KLYOKHSTR2024-02-23
B773KMHBD0KLYOKMHBD2024-02-23
B773KLEDL0KLYOKLED-L2024-02-22
B773KLEDS0KLYOKLED-S2024-02-22
B773KEOPT0KLYOKEOPT2024-02-21
B773KLTEM77KLYOKL2023-05-24
B773KLEDM0KLYOKLED-M2019-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250435526996DORO® Lubricant HP500 Black Forest Medical GmbHFWX2023-07-26
04250435528129DORO® Lubricant HP500 Black Forest Medical GmbHFWX2023-07-26
B773KLTEM77KLYOKLYO MEDICAL SYSTEMS INC.FWX2023-05-24
07630040744966Hip InstrumentsMedacta International SAFWX2021-11-10
07630040728027Hip InstrumentsMedacta International SAFWX2021-05-10
07630040754521HIP InstrumentsMedacta International SAFWX2020-12-09
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07630040735742Hip InstrumentsMedacta International SAFWX2020-07-09
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07630040735735Hip InstrumentsMedacta International SAFWX2020-07-07
07630040735773Hip InstrumentsMedacta International SAFWX2020-07-07
07630040735810Hip InstrumentsMedacta International SAFWX2020-07-07
07630040735841Hip InstrumentsMedacta International SAFWX2020-07-07
07630040734714Hip InstrumentsMedacta International SAFWX2020-07-02