# K242774: SpydrBlade Flex Instrument (PRD-RG1-001)

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Jun 6, 2025 after 266 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: 1 generation back to K230328 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230328: Speedboat Flush SB1 Instrument, Creo Medical, Ltd. (2023) Summary page 5.

## Indications for use
The SypdrBlade Flex Instrument is indicated for use in the cutting (incision, dissection, avulsion) of soft tissue using radiofrequency energy and the coagulation (hemostasis, cauterization, arrest of bleeding) of soft tissue using microwave energy in the gastrointestinal tract as required or encountered in endoscopic procedures. The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K242774
Methodology: https://510kreport.com/methodology