# K171983: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Aug 17, 2017 after 48 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K854238 (1985). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092309: Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L, Olympus Medical Systems Corporation (2009) Summary page 4.
- K133933: Injection Gold Probe Bipolar Electrohemostasis Catheter, Boston Scientific Corporation (2014) Summary page 4.
- K083452: Erbe Model Vio 300 D with Accessories, Erbe USA, Inc. (2008) Summary page 4.

## Most influential descendants
- K192905: Creo Electrosurgical System with HS1 Hemostasis Accessory (2020), 0 descendants of its own

## Indications for use
Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.

Source page: https://510kreport.com/device/K171983
Methodology: https://510kreport.com/methodology