# K983647: Echo-Coat Ultrasound Needles

- Pathway: 510(k) (Traditional)
- Applicant: Sts Biopolymers
- Decided: Jan 20, 1999 after 96 days
- Product code: MJG (Device, Percutaneous, Biopsy)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851957 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851957: Chiba Needle, Wilson-Cook Medical, Inc. (1985) Summary page 1.

## Indications for use
The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle, The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.

Source page: https://510kreport.com/device/K983647
Methodology: https://510kreport.com/methodology