510(k) · Cleared
ClearedColorado Microdissection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 3, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- May 3, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 5 citing it directly.
- This deviceK000348 Colorado Microdissection NeedleStryker Leibinger · 2000
- Descendant · cites it directly · 6 of its ownK073046 Ethicon Endo Surgery Articulating Needle Knife, Model 2504Ethicon Endo-Surgery, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK033232 Colorado Microdissection NeedleStryker Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK082955 Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK082114 Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00…Apollo Endosurgery, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK072124 Black and Black Electrosurgical Cutting and Coagulation Forceps and…Black & Black Surgical, Inc. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K073046Ethicon Endo Surgery Articulating Needle Knife, Model 2504Ethicon Endo-Surgery, Inc. · 2008 · cites it directly6descendants
- K033232Colorado Microdissection NeedleStryker Corp. · 2004 · cites it directly5descendants
- K082955Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc. · 2009 · 2 generations on2descendants
- K082114Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Apollo Endosurgery, Inc. · 2008 · 2 generations on2descendants
- K072124Black and Black Electrosurgical Cutting and Coagulation Forceps and ElectrodesBlack & Black Surgical, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000348 | Colorado Microdissection Needle | Stryker Leibinger | 2000 | — |
| +1 | K073046 | Ethicon Endo Surgery Articulating Needle Knife, Model 2504 | Ethicon Endo-Surgery, Inc. | 2008 | — |
| +1 | K033232 | Colorado Microdissection Needle | Stryker Corp. | 2004 | — |
| +2 | K082955 | Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505 | Ethicon Endo-Surgery, Inc. | 2009 | — |
| +2 | K082114 | Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 | Apollo Endosurgery, Inc. | 2008 | — |
| +2 | K072124 | Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes | Black & Black Surgical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K073046 (Ethicon Endo-Surgery, Inc., 2008) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K000348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000348: 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/K000348
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026