# K801760: Field-Lee Brain Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: American V. Mueller
- Decided: Sep 9, 1980 after 43 days
- Product code: HAO (Instrument, Surgical, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 882.4535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K060808: Brainpro, Brainpro Access (2006), 3 descendants of its own
- K220897: Disposable Brain Biopsy Needle 2.0 (2022), 1 descendant of its own
- K230201: Disposable Pre-calibrated Brain Biopsy Needle 2.0 (2023), 0 descendants of its own
- K112094: Brain Biopsy Needle (2012), 0 descendants of its own
- K974158: Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K801760
Methodology: https://510kreport.com/methodology