Catalog Number
-
Brand Name
Endo Clip
Version/Model Number
176502
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 2016
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K954435,K954435
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
e7c3567d-3666-4d10-9aa3-fd7a4d609f38
Public Version Date
August 22, 2022
Public Version Number
7
DI Record Publish Date
August 28, 2015
Package DI Number
20884521057712
Quantity per Package
6
Contains DI Package
10884521057715
Package Discontinue Date
March 25, 2016
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |