510(k) · Cleared
ClearedMicro Diamond-Point Dissection Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dsp Worldwide · JOS Electrode, Electrosurgical
Cleared on Sep 20, 1996 as substantially equivalent to K881763 (Colorado Biomedical, Inc., 1988) after an 84-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Sep 20, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- JOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881763 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK881763 Colorado Needle ElectrodeColorado Biomedical, Inc. · 1988
- This deviceK962544 Micro Diamond-Point Dissection NeedlesDsp Worldwide · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881763 | Colorado Needle Electrode | Colorado Biomedical, Inc. | 1988 | — |
| 0 (this device) | K962544 | Micro Diamond-Point Dissection Needles | Dsp Worldwide | 1996 | — |
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 JOS? 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 |
|---|---|---|---|
| * | K881763 | Colorado Needle ElectrodeSummary page 1…cutting and coagulation device 5. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed: Colorado MicroDissection Needle (K881763) Addendum to K962544 9/12/96 Attachment 3 - Page 1 DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles === Pag… | 1988 |
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 K881763.
How does its category compare?
All JOS devicesJOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JOS
Too few JOS 510(k)s in any year since 2007 to give a median.
Recalls per year · JOS
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOS
6in 2025
MAUDE reports naming product code JOS, 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 | — | 0 | 29 |
| 2008 | 0 | — | 1 | 37 |
| 2009 | 0 | — | 0 | 62 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 2 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 2 | 17 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are electrosurgical electrodes which are intended for use as accessorics to clectrosurgical devices to cut tissuc (dissection) and control bleeding for general, plastc, and reconstructive surgery.
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/K962544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962544: Micro Diamond-Point Dissection Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962544
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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