# K083358: Lubricano-Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Farco Pharma GmbH
- Decided: Jan 9, 2009 after 87 days
- Product code: MUI (Media, Coupling, Ultrasound)
- 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
Longest line of descent: 1 generation back to K033178 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042619: Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant, Sonotech, Inc. (2004) Summary page 1.
- K033178: Ultrabio, Sonotech, Inc. (2004) Summary page 1.
- K081990: Lubricano Sterile Gel, Farco Pharma GmbH (2008). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K211691: Ultrast Gel (2021), 0 descendants of its own

## Indications for use
Sterile gel for acoustic coupling in ultrasound indications Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography. Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.

Source page: https://510kreport.com/device/K083358
Methodology: https://510kreport.com/methodology