Cytological Cervical Spatula Multi-Spatula

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Cytological Cervical Spatula the Multi-Spatula

510(k) Number

K851934 ↗

FDA Product Code

HHT

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K853059 Active Cleared 10 Jan 1986

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  FDA 510(k) K842609 Active Cleared 9 Aug 1984

• Laborie Urodynamics Processor

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  FDA 510(k) K852856 Active Cleared 17 Oct 1985

• What is the Multi-Spatula Cervical Cytology Spatula used for?

  The Multi-Spatula Cervical Cytology Spatula is specifically designed to collect epithelial cells from the cervix, particularly from the transformation zone. This aids in Pap smear screening and other cytological evaluations to detect abnormal cellular changes, helping clinicians identify potential cervical abnormalities early.

• Is the Multi-Spatula Cervical Cytology Spatula intended for single-use or reuse?

  This device is supplied as a single-use instrument. It is not intended for reuse, and proper disposal after use is required to maintain clinical safety and sterility standards. Reuse could compromise the integrity of the device and introduce infection risks.

• What regulatory pathway does the Multi-Spatula Cervical Cytology Spatula follow?

  The Multi-Spatula Cervical Cytology Spatula is regulated under the FDA 510(k) clearance process as a Class II medical device (Product Code: HHT). It was granted clearance under the Traditional 510(k) pathway with a decision date of July 5, 1985, and is classified under the Obstetrics/Gynecology specialty. The clearance number is K851934.

• How should the Multi-Spatula Cervical Cytology Spatula be stored?

  While specific storage instructions are not detailed in the regulatory data, single-use medical devices like this spatula should generally be stored in a clean, dry environment, protected from contamination and physical damage. Follow manufacturer guidelines for optimal shelf life and sterility preservation, as improper storage could compromise device performance.

• Is there any MRI safety information provided for this device?

  The regulatory data for the Multi-Spatula Cervical Cytology Spatula does not include any MRI safety information. Since it is a single-use, non-metallic device intended for brief clinical use, MRI compatibility is unlikely to be a concern, but clinicians should confirm compatibility with their specific MRI systems if needed.