Duns Number:544357082
Device Description: EndoClot Submucosal Injection SystemEndoClot® Submucosal Injection Agent is intended for u EndoClot Submucosal Injection SystemEndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal liftof polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare orendoscopic device.
Catalog Number
SIS-30
Brand Name
EndoClot
Version/Model Number
SIS-30
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
K191254,K191254
Product Code
PLL
Product Code Name
Submucosal Injection Agent
Public Device Record Key
c7d8495c-eef3-4afb-ae11-8d26283b84d2
Public Version Date
February 18, 2021
Public Version Number
1
DI Record Publish Date
February 10, 2021
Package DI Number
26972011720216
Quantity per Package
5
Contains DI Package
16972011720219
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |