# K931644: Gertie Marx Needle

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Medical-Dental Products USA, Inc.
- Decided: Sep 22, 1993 after 173 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K070354: Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) (2007), 7 descendants of its own
- K131006: Anesthesia Conduction Needles (2013), 5 descendants of its own
- K142553: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (2015), 3 descendants of its own
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (2018), 2 descendants of its own
- K212982: Medispine - Spinal Needle, Glospine - Spinal Needle (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K931644
Methodology: https://510kreport.com/methodology