H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray & Multipurpose Procedure Tray

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K020954 ↗

FDA Product Code

LKF

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Ackrad Endotracheal Tube Introducing Guide

  Class I

  FDA 510(k) K844557 Active Cleared 17 Dec 1984

• Nicos (Non-Invasive Cardiac Output System)

  Class I

  FDA 510(k) K904499 Active Cleared 1 Jul 1991

• Ackrad Bronchitrac

  Class I

  FDA 510(k) K822398 Active Cleared 4 Oct 1982

• Modified Infant Nasal Cannulae Assembly

  Class II

  FDA 510(k) K895031 Active Cleared 30 Oct 1989

• Ackrad Hysterosalpingography Set

  Class II

  FDA 510(k) K842231 Active Cleared 19 Sep 1984

• N-D0-Sure

  Class I

  FDA 510(k) K811185 Active Cleared 2 Jun 1981

See all devices from Ackrad Laboratories →

• What procedures are these trays designed for?

  These trays are specifically designed for obstetrics and gynecology procedures involving the female reproductive tract. They facilitate the delivery of diagnostic contrast media agents to enable imaging of the uterus, such as hysterography or saline infusion sonography. The different variants (5F, 7F, elliptosphere, and multipurpose) accommodate varying procedural needs.

• Are these trays single-use or reusable?

  These trays are intended for single-use only in clinical settings. This design ensures patient safety and sterility, as single-use devices eliminate the risk of cross-contamination between patients.

• What components are included in each tray?

  Each tray includes cannulas, injectors, and other accessories tailored for uterine procedures. The components are designed to work together to deliver diagnostic contrast media agents during imaging studies like hysterography or saline infusion sonography.

• Are these trays sterile when supplied?

  Yes, these trays are supplied sterile. Sterility is a critical factor for medical devices used in invasive procedures, ensuring safety and reducing infection risks for patients.

• What regulatory status does this device hold?

  This device holds an FDA 510(k) clearance with a Substantially Equivalent determination, filed under product code LKF and reviewed by the Obstetrics/Gynecology Advisory Committee. It is classified as a Class II device under regulation number 884.4530.