FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K Number: K241333
·
Decision Jan 17, 2025
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
1
Review Days
252
Basic Information
- Device Name
- Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- K Number
- K241333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koh Young Technology Inc.
- Date Received
- May 10, 2024
- Decision Date
- January 17, 2025
- 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 |
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