# K843719: Single Wall Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ocean Medical Products, Ltd.
- Decided: Oct 18, 1984 after 24 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982890: Advanced Uroscience Injection Needle (1998), 20 descendants of its own
- K990996: Genyx Medical Injection Needle (1999), 13 descendants of its own
- K022484: Cook Injection Needle (2002), 12 descendants of its own
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- K051905: Uroplasty Rigid Endoscopic Needle (2005), 3 descendants of its own

Source page: https://510kreport.com/device/K843719
Methodology: https://510kreport.com/methodology