FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Disposable Intraoperative Probe (DIOP8)
K Number: K201425
·
Decision Feb 19, 2021
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
3
Review Days
266
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Disposable Intraoperative Probe (DIOP8)
- K Number
- K201425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huntleigh Healthcare Limited
- Date Received
- May 29, 2020
- Decision Date
- February 19, 2021
- 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-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
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