Data / Medical devices / Taiwan / Point Robotics Medtech Inc.
Point Robotics Medtech Inc.: FDA-registered device maker in Xindian Dist. New Taipei, Taiwan, 5 510(k) clearances
Point Robotics Medtech Inc. is registered with the FDA (registration 3021976927) in Xindian Dist. New Taipei, Taiwan. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated February 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021976927
- Address
- 7F., No. 219, Sec. 3, Beixin Rd., Xindian Dist. New Taipei, Taiwan, 231
- Owner or operator
- Point Robotics MedTech Inc. (10084311)
- Roles
- Manufacturer
- First device listed
- November 3, 2022
- Registered through
- 2026
- Brand names listed
- "POINT" Kinguide Agile Hybrid Navigation System, "POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System, Advanced Tool Kit; Advanced Tool Kit Snap, Anti-Slip Ring-ø7*5mm (Non-Sterile), Anti-Slip Ring-ø8*10mm (Non-Sterile), Camera Cart, DRF Accessories Set, DRF Accessories Set (C); DRF Accessories Set (C) Snap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2026 | K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | OLO | Substantially Equivalent | Point Robotics MedTech, Inc. | accessdata.fda.gov |
| January 23, 2026 | K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | OLO | Substantially Equivalent | Point Robotics MedTech, Inc. | accessdata.fda.gov |
| July 24, 2024 | K241130 | POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | OLO | Substantially Equivalent | Point Robotics MedTech, Inc. | accessdata.fda.gov |
| July 17, 2023 | K230087 | POINT Kinguide Agile Hybrid Navigation System | OLO | Substantially Equivalent | Point Robotics MedTech, Inc. | accessdata.fda.gov |
| August 9, 2022 | K220241 | POINT Kinguide Robotic-Assisted Surgical System | OLO | Substantially Equivalent | Point Robotics MedTech, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.