510(k) · Cleared
ClearedGlobal Medical Products Brest Lesion Localization Needle with Stiffened Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Medical Products, Ltd. · GDF Guide, Needle, Surgical
Cleared on May 26, 1995 after a 130-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- May 26, 1995
- Review
- 130 days
- Class
- Class I
- Product code
- GDF
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GDF? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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.
How does its category compare?
All GDF devicesGDF Guide, Needle, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDF
FDA has decided no GDF device since 2007.
Median 510(k) review, days · GDF
Too few GDF 510(k)s in any year since 2007 to give a median.
Recalls per year · GDF
4in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GDF
19in 2025
MAUDE reports naming product code GDF, 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 | 0 | — | 6 | 9 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 1 | 6 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 4 | 15 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950311 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950311: Global Medical Products Brest Lesion Localization Needle with Stiffened Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950311
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026