# K934370: Bip Biopsy Needle Modification

- Pathway: 510(k) (Traditional)
- Applicant: Bip USA, Inc.
- Decided: Mar 7, 1994 after 181 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K242228: Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) (2025), 0 descendants of its own

## Recalls of this device
- Aug 2, 2024 · Class II · Z-3206-2024: Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
- Oct 8, 2009 · Not classified · Z-0273-2010: The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a lo
- Oct 8, 2009 · Not classified · Z-0274-2010: The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a lo
- Oct 8, 2009 · Not classified · Z-0275-2010: The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a lo
- Oct 8, 2009 · Not classified · Z-0276-2010: The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a lo

Source page: https://510kreport.com/device/K934370
Methodology: https://510kreport.com/methodology