Duns Number:118244987
Device Description: The POC endoscope is intended use for endoscopic viewing of internal surgery sites during The POC endoscope is intended use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with endoscopic instrument control systems during laparoscopic and thoracoscopic surgical procedures.
Catalog Number
-
Brand Name
0 Deg 10mm 425mm Lg, Laparoscope
Version/Model Number
6761-903
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K914084
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
304efdc3-968c-485c-b87d-e9554b4c489d
Public Version Date
March 31, 2021
Public Version Number
1
DI Record Publish Date
March 23, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |