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F.M. Wiest USA, Inc.

Also registered as Wiest USA, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
13

What F.M. Wiest USA, Inc. makes

F.M. Wiest USA, Inc. manufactures surgical and diagnostic devices for orthopedic, urologic, and gynecologic procedures, including automated arthroscopic irrigation systems (e.g., ARTHRO AUTOMAT 5002, ARTHROFLATOR), hysteroscopic fluid management systems (e.g., HYSTEROMAT 3700, HYSTEROFLATOR 1500), and urodynamic assessment equipment (e.g., F.M. WEIST KG URODYNAMIC SYSTEMS, URETEROMAT 4400). The portfolio also includes laparoscopic fluid control devices (e.g., LAPAROFLATOR 3000, LAPAROFLATOR ELECTRONIC 3509) and specialized systems for controlled fluid and pressure management in surgical settings, such as the MERKUR 4000 and CAMSYS 6300.

The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. These products are intended for use in the United States, where the manufacturer is based.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

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  • Arthro Automat 5002 Ref K871180

    Class II
    Active 510(k) 510(k) II

  • Cavomat Ref K911388

    Class II
    Active 510(k) 510(k) II

  • Laparoflator 3000, Standard And Electronic Ref K875137

    Class II
    Active 510(k) 510(k) II

  • Hysteromat(Tm) 3700 Ref K921871

    Class II
    Active 510(k) 510(k) II

  • Merkur 4000 Ref K920575

    Class II
    Active 510(k) 510(k) II

  • F.M. Weist, KG (Urodynamic Systems) Ref K860571

    Class II
    Active 510(k) 510(k) II

  • Camsys 6300 Ref K920574

    Class II
    Active 510(k) 510(k) II

  • Arthroflator Ref K865066

    Class II
    Active 510(k) 510(k) II

  • Laparoflator Electronic 3509 Ref K910883

    Class II
    Active 510(k) 510(k) II

  • Arthrocombi 5003 Ref K871181

    Class II
    Active 510(k) 510(k) II

  • Ureteromat 4400 Ref K915751

    Class II
    Active 510(k) 510(k) II

  • Space(Tm) 7500 Ref K912071

    Class II
    Active 510(k) 510(k) II

  • Hysteroflator 1500 Ref K911844

    Class II
    Active 510(k) 510(k) II

Rows 1-13 of 13

Frequently asked questions

How many devices does F.M. Wiest USA, Inc. have in the registry?

The registry currently lists 13 devices for F.M. Wiest USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list F.M. Wiest USA, Inc.'s devices?

Among its 13 most recently registered devices, F.M. Wiest USA, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do F.M. Wiest USA, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for F.M. Wiest USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from F.M. Wiest USA, Inc. in the registry?

The most recently registered devices listed for F.M. Wiest USA, Inc. include ARTHRO AUTOMAT 5002, CAVOMAT, LAPAROFLATOR 3000, STANDARD AND ELECTRONIC and HYSTEROMAT(TM) 3700.

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