# K250351: Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 10, 2025 after 245 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: 10 generations back to K952726 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 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 5.
- K182408: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645, Olympus Medical Systems Corp. (2019) Summary page 5.
- K171158: Single Use Electrosurgical knife, Olympus Medical Systems Corp. (2017) Summary page 5.

## Indications for use
The Single Use Electrosurgical Knife KD-612 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units. The Single Use Electrosurgical Knife KD-620UR is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units. The Single Use Electrosurgical Knife KD-650 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

Source page: https://510kreport.com/device/K250351
Methodology: https://510kreport.com/methodology