# K150271: Prime Adaptive Ultrasonic Scalpel System

- Pathway: 510(k) (Traditional)
- Applicant: Endoprime, Inc.
- Decided: May 29, 2015 after 114 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952726 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002981: Ultracision Harmonic Scalpel Coagulating Shears, Model LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150, Ethicon Endo-Surgery, Inc. (2001) Summary page 7.
- K990430: Ultracision Harmonic Scalpel Hand Piece, Ethicon Endo-Surgery, Inc. (1999) Summary page 7.
- K010898: Ultracision Harmonic Scalpel Blades, Model DH105,DH145,SH105, SH145,HC145, Ethicon Endo-Surgery, Inc. (2001) Summary page 7.
- K053056: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 7.

## Indications for use
The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic, and endoscopic 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.

Source page: https://510kreport.com/device/K150271
Methodology: https://510kreport.com/methodology