# K230328: Speedboat Flush SB1 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Oct 31, 2023 after 267 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K190317: Zavation Spinal System, Zavation Medical Products, LLC (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K242774: SpydrBlade Flex Instrument (PRD-RG1-001) (2025), 0 descendants of its own
- K242983: CROMA Electrosurgical Generator (PRD-EMR-050) (2025), 0 descendants of its own
- K242061: Reusable Interface Cable 1.5 m (PRD-IFC-002) (2024), 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/K230328
Methodology: https://510kreport.com/methodology