Duns Number:338430324
Device Description: THD SensyProbe is an innovative single-use probe to be used with the Anopress device to pe THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform a THD anorectal manometry examination. THD SensyProbe allows measuring of the actual mean sphincter tone pressure in the various functional activations (resting, squeeze and strain tone). In addition, thanks to a balloon fitted at the end of the probe and connection via a dedicated line, THD SensyProbe allows analysing the rectal ampulla volume and hence assessing rectal sensitivity and anorectal inhibitory reflex (this measurement can be made after inflating the balloon with the dedicated THD SensyProbe Accessory). THD SensyProbe does not need to be calibrated, as this is automatically done each time a procedure with THD Anopress is started.The probe is equipped with an ergonomic grip and has a fully atraumatic tip ensuring maximum comfort for the medical staff and the patient during the examination, and it has been dimensioned so as to reproduce the conditions during a normal digital exploration. A Probe Card to record the examination is included in the package.
Catalog Number
710010
Brand Name
THD SensyProbe
Version/Model Number
THD SensyProbe
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180135,K180135,K180135
Product Code
KLA
Product Code Name
Monitor, Esophageal Motility, And Tube
Public Device Record Key
4b079b25-f351-4269-b443-1e836d7238b3
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
March 20, 2018
Package DI Number
38033737712284
Quantity per Package
15
Contains DI Package
08033737712290
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cartoon Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |