# K252247: Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 16, 2025 after 90 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955558 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153625: Single Use Injector NM600/610, Olympus Medical Systems Corp. (2016) Summary page 6.

## Indications for use
The Single Use Injector NM-400/401 Series is intended to be used to perform endoscopic vascular or submucosal injection in the digestive tract with an endoscope.

Source page: https://510kreport.com/device/K252247
Methodology: https://510kreport.com/methodology