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Simpson/Basye, Inc.

United StatesFDA applicant, unverified

Devices
12

What Simpson/Basye, Inc. makes

Simpson/Basye, Inc. manufactures medical devices for gynecological and forensic procedures, including endocervical sampling tools like the MI-Mark Endocervical Sampling Set and Campion Cervical Hook. Their portfolio also covers surgical accessories such as the Newport Cervical Manipulator and laser-related instruments, including the Campion Laser Forceps and Surgical Laser Accessories Case. Additional products include forensic evidence kits for sexual assault cases, vaginal and anal specula, and reusable surgical instruments like the Sedlacek Handle and heated instrument bath.

The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These instruments are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

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

Catalogue12

Newest first, rows 1-12 of 12

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  • Hand Mirror (Endoscope) Ref K862717

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

  • Mi-Mark Endocervical Sampling Set Ref K790923

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

  • Sexual Assault Forencic Evidence Kit Ref K772298

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

  • Newport Cervical Manipulator Ref K891350

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

  • Surgical Laser Accessories (Sla) Case Ref K862629

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

  • Campion Cervical Hook Ref K891349

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

  • Reid Endocervical Spreader Ref K891347

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

  • Sedlacek Handle Ref K926179

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

  • Heated Instrument Bath Ref K870276

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

  • Newport Lateral Vaginal Retractor Ref K891351

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

  • Campion Laser Forceps Ref K891348

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

  • Marlow Anal Speculum Ref K891352

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Simpson/Basye, Inc. have in the registry?

The registry currently lists 12 devices for Simpson/Basye, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Simpson/Basye, Inc.'s devices?

Among its 12 most recently registered devices, Simpson/Basye, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Simpson/Basye, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Simpson/Basye, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Simpson/Basye, Inc. in the registry?

The most recently registered devices listed for Simpson/Basye, Inc. include HAND MIRROR (ENDOSCOPE), MI-MARK ENDOCERVICAL SAMPLING SET, SEXUAL ASSAULT FORENCIC EVIDENCE KIT and NEWPORT CERVICAL MANIPULATOR.

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