Hybrisonic Sheath

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

510(k) Number

K983985 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sonogel

  Class II

  FDA 510(k) K953468 Active Cleared 17 Oct 1995

• Sonoscan

  Class II

  FDA 510(k) K961692 Active Cleared 22 Aug 1996

• Ultramix

  Class II

  FDA 510(k) K962093 Active Cleared 23 Dec 1996

• Endo-Glide

  Class II

  FDA 510(k) K013701 Active Cleared 4 Feb 2002

• Oasis

  Class II

  FDA 510(k) K964658 Active Cleared 14 Feb 1997

• Vivosonic

  Class II

  FDA 510(k) K984562 Active Cleared 8 Jun 1999

See all devices from Sonotech, Inc. →

• What is the Hybrisonic Sheath used for in medical imaging procedures?

  The Hybrisonic Sheath is designed as a couplant to improve ultrasound imaging quality. It acts as a medium between the ultrasound transducer and the patient’s skin, ensuring better transmission of sound waves. This enhances clarity and diagnostic accuracy during invasive diagnostic ultrasound procedures, particularly in sterile environments like radiology exams.

• Is the Hybrisonic Sheath meant for single-use or can it be reused?

  The Hybrisonic Sheath is explicitly supplied as a single-use consumable. This design ensures sterility and safety for each procedure, preventing cross-contamination between patients. Reuse is not recommended or supported by the manufacturer.

• How is the Hybrisonic Sheath regulated and what does its FDA classification mean?

  The Hybrisonic Sheath holds FDA 510(k) clearance (K983985) and is classified as a Class II medical device. This classification means it undergoes rigorous review by the FDA’s Radiology Advisory Committee (RA) to ensure it meets safety and effectiveness standards for use as a couplant in ultrasound imaging. The ‘substantially equivalent’ decision indicates it performs similarly to a legally marketed device already on the market.

• Does the Hybrisonic Sheath require any special storage conditions?

  The provided data does not specify storage requirements beyond its use in sterile environments. Since it is a single-use consumable, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures until use. Always follow manufacturer guidelines for unopened packaging to maintain sterility.