FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
K Number: K994421
·
Decision Feb 23, 2000
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
3
Review Days
56
Basic Information
- Device Name
- SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
- K Number
- K994421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SURGICAL NAVIGATION SPECIALISTS, INC.
- Date Received
- December 29, 1999
- Decision Date
- February 23, 2000
- Product Code
- HAW
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.
EZ-FIDUCIALS
FDA 510(k)
FDA Class 2
·Neurology
Stereotaxic Guiding Surgical Devices, NaoTrac S
FDA 510(k)
FDA Class 2
·Neurology
Navient Image Guide Navigation System (955-NC-NC), Cranial
FDA 510(k)
FDA Class 2
·Neurology
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
FDA 510(k)
FDA Class 2
·Neurology
ClearPoint System (Software Version 3.0)
FDA 510(k)
FDA Class 2
·Neurology
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
FDA 510(k)
FDA Class 2
·Neurology