Duns Number:713565195
Device Description: The product is comprised of a minimally invasive surgical trocar (Outer sheath sleeve, Inn The product is comprised of a minimally invasive surgical trocar (Outer sheath sleeve, Inner trocar and Optical obturator) and accessories (Lens cleaning syringe and Lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insuf ation and the other attached to the Inner trocar is used for the objective lens cleaning function. The design of the InterLock Trocar maintains the laparoscope and the hand instrument in direct alignment. This feature provides a surgeon with control of the laparoscope image and the hand instrument with one hand, meaning the laparoscope is in direct alignment or parallel to the hand instrument. The hand instrument is always in the eld of view of the laparoscope. The laparoscope does not need to be held by another surgeon or health care personnel. The InterLock Trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparosco
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
DLT05S
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
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
K170084,K170084
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
c3f0deba-b0a6-4f05-90f7-efab00224fde
Public Version Date
December 17, 2020
Public Version Number
1
DI Record Publish Date
December 09, 2020
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 | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |