Duns Number:961656951
Device Description: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm no The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue.
Catalog Number
-
Brand Name
Canady Hybrid Plasma Scalpel
Version/Model Number
AW-422554
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 23, 2020
Issuing Agency
In HIBCC
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"
-
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
K113500
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
d33219bf-4f75-4801-b4f4-b3c9360ca088
Public Version Date
March 23, 2020
Public Version Number
3
DI Record Publish Date
March 05, 2018
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. | 7 |