Search Results
Found 1 results
510(k) Data Aggregation
K Number
K150271Device Name
Prime Adaptive Ultrasonic Scalpel System
Manufacturer
Date Cleared
2015-05-29
(114 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ENDOPRIME, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.
Device Description
The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the ultrasonic power output for the tissue load encountered.
Ask a Question
Ask a specific question about this device
Page 1 of 1