# K200404: ORISE ProKnife

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 3, 2020 after 288 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: 9 generations back to K952726 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171158: Single Use Electrosurgical knife, Olympus Medical Systems Corp. (2017) Summary page 4.
- K083608: Erbe Hybrid Knife, Erbe USA, Inc. (2009) Summary page 4.

## Indications for use
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.

Source page: https://510kreport.com/device/K200404
Methodology: https://510kreport.com/methodology