# K983985: Hybrisonic Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Sonotech, Inc.
- Decided: Feb 25, 1999 after 108 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Couplant: HybriSonic Sheaths will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics, provide lubrication and act as a microbial barrier. HybriSonic Sheaths are intended for use in sterile and non-sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polypropylene protective transducer cover. The HybriSonic Sheath is sufficiently lubricous to be used without additional lubrication for transcutaneous ultrasound such as ultrasound guided biopsy and aspiration. Microbial barrier: HybriSonic Sheaths are also intended for use as ultrasound transducer microbial barriers that are in vivo biocompatible with tissue and body fluids and leave no residue after use, as they remain with the transducer, are single use and disposable. Device lubricant: In addition to coupling ultrasound, the HybriSonic Sheath is intended for use as a device lubricant and microbial barrier during transcutaneous ultrasound exams and with intraoperative ultrasound, endocavitary ultrasound imaging and transcutaneous ultrasound guided biopsy or aspiration.

Source page: https://510kreport.com/device/K983985
Methodology: https://510kreport.com/methodology