KONIX STERILE GEL
FDA 510(k) clearance K130581 · decided 2014-06-18
Clearance details
- K-number
- K130581
- Device name
- KONIX STERILE GEL
- Applicant
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
- Decision
- Substantially Equivalent
- Date received
- 2013-03-05
- Decision date
- 2014-06-18
- Days to decision
- 470 days
- Clearance type
- Traditional
- Product code
- MUI
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2 recall (Z-0777-2024) | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. | 2024-01-20 |
| ASG-001; Ultrasound gel recall (Z-2532-2023) | Advance Medical Designs, Inc. | 2023-09-09 |
| 50-GEL20; Ultrasound gel recall (Z-2533-2023) | Advance Medical Designs, Inc. | 2023-09-09 |
| Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. C recall (Z-2290-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-08-03 |