# K972496: Pencil-Grip Fna Syringe Holder and Effortless Needle Remover

- Pathway: 510(k) (Traditional)
- Applicant: Tao & Tao Technologyt, Inc.
- Decided: Dec 9, 1997 after 159 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200278: CytoCore (2020), 0 descendants of its own

## Indications for use
The TAO ASPIRATOR™ is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand. The PLASTIC FINGER™ is an accessory to the TAO ASPIRATOR to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

Source page: https://510kreport.com/device/K972496
Methodology: https://510kreport.com/methodology