Gardosi Birthing Cushion

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K903973 ↗

FDA Product Code

KNC

Device Class

Class II

Regulation

21 CFR Part 884.4900

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Graphic Controls Corp. →

• What is the Gardosi Birthing Cushion used for during labor and delivery?

  It is placed on a delivery table to create a cushioned, supportive surface for the birthing mother, helping improve comfort and allowing better positioning throughout labor and delivery.

• How is the Gardosi Birthing Cushion supplied and what is known about its sterility or reuse?

  The cushion is supplied by Graphic Controls Corp. The available data do not specify whether it is provided sterile, nor whether it is intended for single‑use or reusable applications, so users must follow their own facility protocols for cleaning and sterility.

• What regulatory classification and clearance does the Gardosi Birthing Cushion have?

  It is classified as a Class II medical device (product code KNC) and received traditional FDA 510(k) clearance (K903973) on 27 September 1990, indicating it was found substantially equivalent to a legally marketed predicate device.

• In which clinical settings is the Gardosi Birthing Cushion intended to be used?

  The device is intended for obstetrics and gynecology environments, specifically for use on obstetric tables during labor and delivery to support the mother.

• Are there any special storage or safety considerations noted for the Gardosi Birthing Cushion?

  The device description does not include information on storage conditions or MRI safety, so standard medical device storage practices and facility-specific safety assessments should be applied.