Duns Number:600165869
Device Description: The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the Hand The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the HandXTM device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors’ rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons’ needs relating to the application of monopolar diathermy for various surgical purposes.The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.
Catalog Number
20-30-073-01
Brand Name
Monopolar Hook
Version/Model Number
20-30-044-01
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"
-
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
K203603,K203603
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
adc7cc3b-f572-487f-b83a-47bd35a257ff
Public Version Date
January 26, 2022
Public Version Number
2
DI Record Publish Date
June 06, 2021
Package DI Number
17290017376087
Quantity per Package
6
Contains DI Package
07290017376080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |