SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
FDA 510(k) clearance K013721 · decided 2001-12-28
Clearance details
- K-number
- K013721
- Device name
- SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
- Applicant
- CIVCO Medical Instruments Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-09
- Decision date
- 2001-12-28
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kalona, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folde recall (Z-1400-2015) | Civco Medical Instruments Inc | 2015-04-08 |
| CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packa recall (Z-1607-2011) | Civco Medical Instruments Inc | 2011-03-08 |
| CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telesc recall (Z-2242-2010) | Civco Medical Instruments Inc | 2010-08-20 |