FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TMINI Miniature Robotic System
K Number: K253661
·
Decision Dec 22, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
22
Review Days
32
Basic Information
- Device Name
- TMINI Miniature Robotic System
- K Number
- K253661
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THINK Surgical, Inc.
- Date Received
- November 20, 2025
- Decision Date
- December 22, 2025
- 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 THINK Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260010 | TMINI® Miniature Robotic System | Mar 3, 2026 | Substantially Equivalent |
| K252544 | TMINI Miniature Robotic System | Oct 10, 2025 | Substantially Equivalent |
| K250877 | TMINI Miniature Robotic System | Jun 20, 2025 | Substantially Equivalent |
| K243481 | TMINI Miniature Robotic System | Jan 6, 2025 | Substantially Equivalent |
| K243285 | TMINI Miniature Robotic System | Nov 15, 2024 | Substantially Equivalent |
| K242264 | TMINI Miniature Robotic System | Aug 23, 2024 | Substantially Equivalent |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | Jul 12, 2024 | Substantially Equivalent |
| K232802 | TMINI Miniature Robotic System | Oct 12, 2023 | Substantially Equivalent |
| K230202 | TMINI Miniature Robotic System | Apr 25, 2023 | Substantially Equivalent |
| K203468 | TCAT TKA Instrument Tray | Dec 20, 2021 | Substantially Equivalent |