FDA 510(k)
FDA class 2
Unknown
🇬🇧 United Kingdom
ScanNav Anatomy Peripheral Nerve Block
K Number: DEN220024
·
Decision Oct 18, 2022
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
2
Review Days
193
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Basic Information
- Device Name
- ScanNav Anatomy Peripheral Nerve Block
- K Number
- DEN220024
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 868.1980
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Applicant
- Intelligent Ultrasound Limited
- Date Received
- April 8, 2022
- Decision Date
- October 18, 2022
- Product Code
- QRG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| QRG | Ultrasound Guided Nerve Block Assist | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QRG), ordered by most recent decision date.
Nerveblox
FDA 510(k)
FDA Class 2
·Anesthesiology
ScanNav Anatomy Peripheral Nerve Block
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Intelligent Ultrasound Limited
| K Number | Device Name | ||
|---|---|---|---|
| K232787 | ScanNav Anatomy Peripheral Nerve Block | Oct 6, 2023 | Substantially Equivalent |