# K882601: E-Z-EM (R) Lufkin Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: E-Z-Em, Inc.
- Decided: Jul 25, 1988 after 31 days
- Product code: GDM (Needle, Aspiration And Injection, Reusable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K013109: Sonopsy (2002), 0 descendants of its own
- K963565: Mri Needles (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K882601
Methodology: https://510kreport.com/methodology