Duns Number:079825991
Device Description: The PAVmed CarpX is a sterile, single-use, bipolar high frequency electrosurgical device d The PAVmed CarpX is a sterile, single-use, bipolar high frequency electrosurgical device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during minimally invasive or general surgical procedures for tissue cutting, including the isolation and division of ligaments, tendons and fascia such as the transverse carpal ligament for the treatment of carpal tunnel syndrome.
Catalog Number
-
Brand Name
CarpX
Version/Model Number
260-03506
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
K200559
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
c2e18d4c-1ecf-4357-aaa3-96ae03618e9a
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |