510(k) · Cleared
ClearedEcho-Coat Ultrasound Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sts Biopolymers · MJG Device, Percutaneous, Biopsy
Cleared on Jan 20, 1999 as substantially equivalent to K851957 (Wilson-Cook Medical, Inc., 1985) after a 96-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jan 20, 1999
- Review
- 96 days
- Class
- Class I
- Product code
- MJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851957 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK851957 Chiba NeedleWilson-Cook Medical, Inc. · 1985
- This deviceK983647 Echo-Coat Ultrasound NeedlesSts Biopolymers · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851957 | Chiba Needle | Wilson-Cook Medical, Inc. | 1985 | — |
| 0 (this device) | K983647 | Echo-Coat Ultrasound Needles | Sts Biopolymers | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K851957 | Chiba NeedleSummary page 1…TED PREDICATE DEVICES The ECHO-COATw Ultrasound Needles are substantially equivalent to the Disposable Chiba Biopsy Needle for Use with Ultrasound manufactured by Cook (K851957), as modified with the “EchoTip” for ultrasound imaging visibility. B. DEVICE DESCRIPTION STS Biopolymers, Inc. will purchase i… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K851957.
How does its category compare?
All MJG devicesMJG Device, Percutaneous, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJG
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MJG
Too few MJG 510(k)s in any year since 2007 to give a median.
Recalls per year · MJG
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJG
1in 2025
MAUDE reports naming product code MJG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983647: Echo-Coat Ultrasound Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983647
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026