# K110112: Cell-Tissue Converter (CTC) Syringe with Needle

- Pathway: 510(k) (Traditional)
- Applicant: Rongshan LI
- Decided: Apr 20, 2011 after 96 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: 6 generations back to K771205 (1977). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K002381: Pentaferte Single Use Syringes, Model Size=Various Sizes, Pentaferte, S.R.L. (2001) Summary page 1.
- K083514: Terumo Syringe with/Without Needle, Terumo Europe N.V. (2009) Summary page 1.
- K962077: Bard Biopty-Cut Biopsy Needle/with Spacer, C.R. Bard, Inc. (1996) Summary page 1.
- K970872: Pan (Chiba Aspirating Needle), Gallini Intl., Inc. (1997) Summary page 1.

## Indications for use
The MFA Syringe/Needle Device is a syringe with needle intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.

Source page: https://510kreport.com/device/K110112
Methodology: https://510kreport.com/methodology