FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sheathes Ultrasound Probe Covers
K Number: K153212
·
Decision Mar 4, 2016
Classifications
1
FEI Numbers
388
Registration Numbers
389
Same Product Code
407
Applicant Total
1
Review Days
120
Basic Information
- Device Name
- Sheathes Ultrasound Probe Covers
- K Number
- K153212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sheathing Technologies, Inc.
- Date Received
- November 5, 2015
- Decision Date
- March 4, 2016
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
Transducer Probe Cover
FDA 510(k)
FDA Class 2
·Radiology