# K130581: Konix Sterile Gel

- Pathway: 510(k) (Traditional)
- Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
- Decided: Jun 18, 2014 after 470 days
- Product code: MUI (Media, Coupling, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 4 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Sterile Aquasonic® 100 Ultrasound Gel (Parker Laboratories): named in the summary without a submission number

## Recalls of this device
- Jul 7, 2023 · Class II · Z-2533-2023: Ultrasound gel mislabeled with inappropriate use.
- Jul 7, 2023 · Class II · Z-2532-2023: Ultrasound gel mislabeled with inappropriate use.
- Jun 9, 2023 · Class II · Z-0777-2024: Sterility of Ultrasound gel can not be guaranteed.
- May 15, 2023 · Class II · Z-2290-2023: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

## Indications for use
As stated on Label: Contact medium for ultrasonic and electrical transmission gel. Konixt Sterile Gel is sterilized by gamma irrdiation 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 stcrility and in vivo biocompatibiility arc required. It can be used on the skin where the risk for infections is especially high, especially with open tissue Doppler applications; and can be used for cystoscopic and vagina] Doppler and ultrasound examinations. Konix®&Serile Gel can be used on the skin or in open tissue where there is arisk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications

Source page: https://510kreport.com/device/K130581
Methodology: https://510kreport.com/methodology