510(k) Report

FDA applicant

Bip USA, Inc.

Niagara Falls, NY7 decisions1993–20036 recalls

FDA records 7 decisions for Bip USA, Inc. (Niagara Falls, NY) from 1993 to 2003: 7 510(k) clearances. Most are in product codes GDF (Guide, Needle, Surgical) and KNW (Instrument, Biopsy). Its devices cite 4 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Bip USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bip USA, Inc. since 2007.

Recalls per year

1in 2024

2009: 42014: 12024: 1
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bip USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bip USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GDFGuide, Needle, Surgical2decisions
  • KNWInstrument, Biopsy2decisions
  • MJGDevice, Percutaneous, Biopsy1decision
  • FCGBiopsy Needle1decision
  • MDMInstrument, Manual, Surgical, General Use1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K024089Vacuflash Biopsy SystemBip USA, Inc. · 20032cite it
  • K934371Bip Multi ModificationBip USA, Inc. · 19942cite it
  • K934370Bip Biopsy Needle ModificationBip USA, Inc. · 19941cites it

What has FDA decided for it lately?

  • K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003
  • K934371Bip Multi ModificationBip USA, Inc. · 1994
  • K934370Bip Biopsy Needle ModificationBip USA, Inc. · 19945 recalls
  • K935457Localization Wire or Marker - SurgicalBip USA, Inc. · 19941 recall
  • K925870SpacerBip USA, Inc. · 1993
  • K925875Horizontal Needle Guide AttachmentBip USA, Inc. · 1993
  • K925874Breast StabilizerBip USA, Inc. · 1993

All 7 as Bip USA, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K934370BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616…Aug 2, 2024Class II
  • K935457Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037…Aug 26, 2014Class II
  • K934370Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum…Oct 8, 2009
  • K934370Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum…Oct 8, 2009
  • K934370Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum…Oct 8, 2009
  • K934370Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum…Oct 8, 2009