# K000348: Colorado Microdissection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: May 3, 2000 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K073046: Ethicon Endo Surgery Articulating Needle Knife, Model 2504 (2008), 6 descendants of its own
- K033232: Colorado Microdissection Needle (2004), 5 descendants of its own
- K082955: Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505 (2009), 2 descendants of its own
- K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 (2008), 2 descendants of its own
- K072124: Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes (2008), 1 descendant of its own

Source page: https://510kreport.com/device/K000348
Methodology: https://510kreport.com/methodology