# K974158: Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Dec 9, 1997 after 36 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801760 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924348: AD-Tech's Brain Biopsy Needle for Stereotaxic, Ad-Tech Medical Instrument Corp (1992) Summary page 1.
- K801760: Field-Lee Brain Biopsy Needle, American V. Mueller (1980) Summary page 1.

## Indications for use
The Orion Medical Disposable Brain Biopsy Needle is an aspiration biopsy needle to remove and sample tissue within the brain in conjunction with a sterotactic head frame. The following statement describes the indications for use of Orion Medical's 14 gauge, 16 gauge, and 18 gauge sterotactic disposable brain biopsy needle: Sterotactic biopsy needle used to sample brain tissue or to extract brain tissue samples to determine tissue abnormmality or any deviation from healthy brain tissue. Tissue samples are extracted via the cannula using a syringe to aspirate. The cannula is then removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type. Needile to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.

Source page: https://510kreport.com/device/K974158
Methodology: https://510kreport.com/methodology