Clearance Summary
KONIX ULTRASOUND GEL received FDA 510(k) clearance under submission number K101952, sponsored by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-05-27.
- Submission: K101952
- Applicant / Sponsor: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2011-05-27
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.