Duns Number:071595540
Device Description: APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Braided Cutting Wire
Catalog Number
050053
Brand Name
APOLLO
Version/Model Number
050053
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2016
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
K982557
Product Code
KNS
Product Code Name
Unit, electrosurgical, endoscopic (with or without accessories)
Public Device Record Key
4536dda6-9539-4686-ac1f-11be225427ba
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |