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Bip Biopsy Needle Modification

by Bip USA, Inc. 510(k)

Active United States Open recall

510(k) K934370

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934370 Date7 Mar 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-3206-2024 FDA Class II initiated 2 Aug 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.

  • 4 recalls, same reason

    • Terminated Z-0275-2010 FDA Unclassified (pre-2012) initiated 8 Oct 2009
    • Terminated Z-0273-2010 FDA Unclassified (pre-2012) initiated 8 Oct 2009
    • Terminated Z-0276-2010 FDA Unclassified (pre-2012) initiated 8 Oct 2009
    • Terminated Z-0274-2010 FDA Unclassified (pre-2012) initiated 8 Oct 2009

    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 loose hub connection. The exposed sample chamber will typically result in an inability to obtain the biopsy sample. In the majority of reported cases, there was no injury to the patient or user. When us

Specification

510(k)

510(k) Number
FDA Product Code
FCG
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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