Known Identifiers & Locations
FEI Numbers
1000122656
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0001-2016 |
Histolock Resection Device, US Endoscopy.
An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Reason: The company has determined the sterility cannot be assured for the affected lot.
|
2015-07-14 |
Terminated
|
View Details
|
| Z-0006-2013 |
Endoscopic retrieval device.
The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Reason: When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.
|
2011-11-14 |
Terminated
|
View Details
|
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