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Biopsys Medical, Inc.

United StatesFDA applicant, unverified

Devices
13

What Biopsys Medical, Inc. makes

Biopsys Medical, Inc. manufactures accessories and components for biopsy procedures, including retractors, clamps, needle guides, and modified biopsy needles. Their portfolio also includes surgical staple markers, biopsy device accessories, and specialized probes like the Mammotome biopsy probe and housing. These products support tissue sampling and imaging-guided interventions in diagnostic and interventional radiology.

The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Their products are listed in the FDA’s 510(k) registry, and the company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

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  • Biopsy Device Accessory Ref K951326

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

  • Retractor Arm Clamp Ref K960019

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

  • Micromark Clip Ref K970817

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

  • Surgical Staple Marker Device (Modify) Ref K963015

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

  • Modified Biopsy Needle Ref K951229

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

  • Mammotome Biopsy Probe And Housing (Mammotome) Ref K970565

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

  • Biopsy Needle And Housing Ref K942639

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

  • Modified Biopsy Needle Ref K945133

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

  • Surgical Staple Marker Ref K950006

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

  • Biopsy Device Accessory Ref K945573

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

  • Needle Guide Ref K943863

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

  • Biopsy Needle And Housing Ref K941549

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

  • Biopsy Device Accessory Ref K944252

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

Rows 1-13 of 13

Frequently asked questions

How many devices does Biopsys Medical, Inc. have in the registry?

The registry currently lists 13 devices for Biopsys Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biopsys Medical, Inc.'s devices?

Among its 13 most recently registered devices, Biopsys Medical, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Biopsys Medical, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Biopsys Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Biopsys Medical, Inc. in the registry?

The most recently registered devices listed for Biopsys Medical, Inc. include BIOPSY DEVICE ACCESSORY, RETRACTOR ARM CLAMP, MICROMARK CLIP and SURGICAL STAPLE MARKER DEVICE (MODIFY).

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