Search Results
Found 2 results
510(k) Data Aggregation
(110 days)
FLO-ASSISTANT
The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.
The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.
I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the Flo-Assistant™ device, primarily focusing on its description, intended use, and assertion of substantial equivalence to predicate devices. It does not include details about clinical trials, performance specifications, or study methodologies.
Ask a specific question about this device
(114 days)
FLO ASSISTANT, MODEL 4-250-00
Ask a specific question about this device
Page 1 of 1