FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)
K Number: K241130
·
Decision Jul 24, 2024
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
5
Review Days
91
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Basic Information
- Device Name
- POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)
- K Number
- K241130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Point Robotics MedTech, Inc.
- Date Received
- April 24, 2024
- Decision Date
- July 24, 2024
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Point Robotics MedTech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Feb 20, 2026 | Substantially Equivalent |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Jan 23, 2026 | Substantially Equivalent |
| K230087 | POINT Kinguide Agile Hybrid Navigation System | Jul 17, 2023 | Substantially Equivalent |
| K220241 | POINT Kinguide Robotic-Assisted Surgical System | Aug 9, 2022 | Substantially Equivalent |