Duns Number:076769355
Device Description: A control handle for a flexible manual device intended to be used in combination with a co A control handle for a flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. The device is constructed of a flexible metal coil and plastic tube whose distal end is equipped with grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reuseable device.
Catalog Number
5050
Brand Name
Hobbs Medical Grasping Forceps Handle
Version/Model Number
5050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
K833125
Product Code
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
304ec61a-2778-4d59-8811-1b2523f89d32
Public Version Date
August 21, 2019
Public Version Number
4
DI Record Publish Date
September 21, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |