KONIX STERILE GEL— 510(k) K130581
Substantially EquivalentTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
FDA 510(k) clearance K130581 for KONIX STERILE GEL, Substantially Equivalent on 2014-06-18. Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa. Device class: 2.
Clearance details
- Applicant
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
- Product code
- Code MUI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code MUI
view allMore clearances from Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
view allRecalls naming K130581
K-number listed on FDA's recall record- Z-2532-2023 — ASG-001; Ultrasound gel
- Z-2533-2023 — 50-GEL20; Ultrasound gel
- Z-0777-2024 — REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
- Z-2290-2023 — Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130581.
Data sourced from openFDA. This site is unofficial and independent of the FDA.