# K935457: Localization Wire or Marker - Surgical

- Pathway: 510(k) (Traditional)
- Applicant: Bip USA, Inc.
- Decided: Feb 17, 1994 after 97 days
- Product code: GDF (Guide, Needle, Surgical)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 26, 2014 · Class II · Z-2648-2014: Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of steri

Source page: https://510kreport.com/device/K935457
Methodology: https://510kreport.com/methodology