510(k) · Cleared
ClearedColorado Microdissection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 25, 2004 as substantially equivalent to K000348 (Stryker Leibinger, 2000) after a 142-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 142 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000348 (2000). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK000348 Colorado Microdissection NeedleStryker Leibinger · 2000
- This deviceK033232 Colorado Microdissection NeedleStryker Corp. · 2004
- Descendant · cites it directly · 1 of its ownK072124 Black and Black Electrosurgical Cutting and Coagulation Forceps and…Black & Black Surgical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK242370 Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline…Medline Industries, LP · 2024
- Descendant · cites it directly · 0 of its ownK192128 Sutter Arrowtip Monopolar ElectrodesSutter Medizintechnik GmbH · 2019
- Descendant · 2 generations on · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK082584 Given Electrosurgical NeedleTripps Court Enterprises, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K072124Black and Black Electrosurgical Cutting and Coagulation Forceps and ElectrodesBlack & Black Surgical, Inc. · 2008 · cites it directly1descendant
- K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle…Medline Industries, LP · 2024 · cites it directly0descendants
- K192128Sutter Arrowtip Monopolar ElectrodesSutter Medizintechnik GmbH · 2019 · cites it directly0descendants
- K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · 2 generations on0descendants
- K082584Given Electrosurgical NeedleTripps Court Enterprises, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000348 | Colorado Microdissection Needle | Stryker Leibinger | 2000 | — |
| 0 (this device) | K033232 | Colorado Microdissection Needle | Stryker Corp. | 2004 | — |
| +1 | K072124 | Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes | Black & Black Surgical, Inc. | 2008 | — |
| +1 | K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline… | Medline Industries, LP | 2024 | — |
| +1 | K192128 | Sutter Arrowtip Monopolar Electrodes | Sutter Medizintechnik GmbH | 2019 | — |
| +2 | K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015 | — |
| +1 | K082584 | Given Electrosurgical Needle | Tripps Court Enterprises, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
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 GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K000348 | Colorado Microdissection NeedleSummary page 1…quivalence EOUIVALENT PRODUCTS: The Stryker Colorado MicroDissection Needle isequivalent to the previous version of the 4/14 product cleared under K000348, and the product manufactured by Colorado Biomedical, and cle w' 8 763. Equivalent product information is found inAppen… | 2000 |
| * | — | Colorado Biomedical product Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072124 | Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes | 2008 | 1 |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle… | 2024 | 0 |
| K192128 | Sutter Arrowtip Monopolar Electrodes | 2019 | 0 |
| K082584 | Given Electrosurgical Needle | 2009 | 0 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectomy and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033232: Colorado Microdissection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033232
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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