# K221672: Creo Electrosurgical System with NP1 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Feb 14, 2023 after 250 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K870028 (1987). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200003: NP1 Instrument, Creo Electrosurgical System, Creo Medical, Ltd. (2020) Summary page 4.

## Indications for use
The NP1 MicroBlate Fine Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. The NP1 MicroBlate Fine Instrument is not intended for use in cardiac procedures. The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue. The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical HS1 SlypSeal Instrument, intended for coagulation (hemostasis and cauterization) of soft tissue. The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to the compatible Creo Medical RS2 Speedboat Instrument, intended for coagulation (hemostasis and cauterization) and cutting soft tissue. The Electrosurgical System is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K221672
Methodology: https://510kreport.com/methodology