# K935814: Microvasive (R)/Meditech (R) Asap (TM) 14G Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 14, 1994 after 102 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 3, 2003 · Not classified · Z-1061-03: Sterility of the device may be compromised due to a lack of package integrity

Source page: https://510kreport.com/device/K935814
Methodology: https://510kreport.com/methodology