# K142791: Spectra Soft Tissue Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices
- Decided: Jan 21, 2015 after 117 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: 2 generations back to K851831 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980122: Manan Soft Tissue Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 4.
- K973565: Quick-Care Biopsy Needle, Cook, Inc. (1997) Summary page 5.

## Indications for use
The Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.

Source page: https://510kreport.com/device/K142791
Methodology: https://510kreport.com/methodology