FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Neuralytix iD3 System (NTX-9001)
K Number: K243636
·
Decision Jun 26, 2025
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
34
Applicant Total
1
Review Days
213
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
- Neuralytix iD3 System (NTX-9001)
- K Number
- K243636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuralytix, LLC
- Date Received
- November 25, 2024
- Decision Date
- June 26, 2025
- Product Code
- PDQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDQ), ordered by most recent decision date.
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TELIGEN System Peripheral Motor Nerve Stimulation Indications
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ATEC IOM Accessory Instruments
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PediGuard Threaded
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Neurosign V4 Intraoperative Nerve Monitor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DSG Connect Technology
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat