# K252889: Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Nov 25, 2025 after 76 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: 2 generations back to K972674 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171993: Zimmon Needle Knife Papillotome, Wilson-Cook Medical Inc./Cook Endoscopy (2017) Summary page 6.

## Indications for use
The Single Use 3-Lumen Needle Knife V KD-V441M/V451M are intended to be used for papillotomy in combination with an endoscope and electrosurgical unit.

Source page: https://510kreport.com/device/K252889
Methodology: https://510kreport.com/methodology