Duns Number:344007369
Device Description: The Coag Endo-Dissector is a monopolar electrosurgical instrument for dissection and hemos The Coag Endo-Dissector is a monopolar electrosurgical instrument for dissection and hemostasis using flexible endoscopes • branches for blunt dissection of tissue • good coagulation capabilities between branches • rotatable flexible shaft for precise alignment of tip • curved grasper for precise targeting of the tissue • teeth provide secure grasping of the bleeding area
Catalog Number
200.50
Brand Name
Coag Endo-Dissector
Version/Model Number
165 cm
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
K141794
Product Code
KGE
Product Code Name
Forceps, Biopsy, Electric
Public Device Record Key
49578c0d-3acc-4fff-97f2-5420dc88bab1
Public Version Date
October 31, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |