Sheathes Ultrasound Probe Covers
FDA 510(k) clearance K153212 · decided 2016-03-04
Clearance details
- K-number
- K153212
- Device name
- Sheathes Ultrasound Probe Covers
- Applicant
- Sheathing Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-05
- Decision date
- 2016-03-04
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Morgan Hill, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tape recall (Z-1006-2026) | Sheathing Technologies Inc | 2025-12-31 |