# K192905: Creo Electrosurgical System with HS1 Hemostasis Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Mar 19, 2020 after 156 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: 6 generations back to K854238 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K171983: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory, Creo Medical, Ltd. (2017) Summary page 4.

## Indications for use
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories. The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: • Peptic Ulcers • Dieulafoy Lesions • Mallory-Weiss Tears • Bleeding Polyp Stalks • Arteriovenous Malformations (AVMs) • Angiomata The HS1 also has irrigation capability. Any other use is not recommended.

Source page: https://510kreport.com/device/K192905
Methodology: https://510kreport.com/methodology