# K182765: 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Top Corporation
- Decided: Sep 3, 2019 after 340 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931367 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170218: Vesco Medical NRFit Tip Syringes, Vesco Medical, LLC (2017) Summary page 4.
- K843414: Top Hypodermic Syringe Piston, Top Surgical Manufacturers Co. (1984) Summary page 5.

## Indications for use
The Top NRFit Lock Tip and Slip Tip LOR Syringes and the Additive Slip Tip Syringe are intended to be used with the ISO 80369-6 NRFit neuraxial compliant epidural needles for locating the epidural space, for local administration, and regional administration excluding subarachnoid/spinal block.

Source page: https://510kreport.com/device/K182765
Methodology: https://510kreport.com/methodology