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Bip USA, Inc.

United StatesFDA applicant, unverified

Devices
7

What Bip USA, Inc. makes

Bip USA, Inc. manufactures medical devices for breast surgery and biopsy procedures, including breast stabilizers, biopsy needle modifications, and horizontal needle guide attachments. Their product range also features the Vacuflash biopsy system, surgical spacers, and localization wires or markers.

The company is based in the United States, and its portfolio includes devices classified as Class I and Class II. These products are listed in the FDA 510(k) regulatory registry.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue7

Newest first, rows 1-7 of 7

  • Breast Stabilizer Ref K925874

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Bip Biopsy Needle Modification Ref K934370 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Bip Multi Modification Ref K934371

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Horizontal Needle Guide Attachment Ref K925875

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Vacuflash Biopsy System Ref K024089

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Spacer Ref K925870

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Localization Wire Or Marker - Surgical Ref K935457

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

How many devices does Bip USA, Inc. have in the registry?

The registry currently lists 7 devices for Bip USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bip USA, Inc.'s devices?

Among its 7 most recently registered devices, Bip USA, Inc. has devices listed in FDA 510(k) (7 devices).

What risk classes do Bip USA, Inc.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Bip USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bip USA, Inc. in the registry?

The most recently registered devices listed for Bip USA, Inc. include BREAST STABILIZER, BIP BIOPSY NEEDLE MODIFICATION, BIP MULTI MODIFICATION and HORIZONTAL NEEDLE GUIDE ATTACHMENT.

Generated automatically from registry data and not verified by a human reviewer.