Point Robotics MedTech Inc.
Xindian Dist. New Taipei, TW
POINT ROBOTICS MEDTECH INC. appears in FDA device records in Xindian Dist. New Taipei, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Point Robotics MedTech Inc. between 2022 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | OLO | Substantially Equivalent | |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | OLO | Substantially Equivalent | |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | OLO | Substantially Equivalent | |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation System | OLO | Substantially Equivalent | |
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021976927 | 3021976927 | POINT ROBOTICS MEDTECH INC. | 7F., No. 219, Sec. 3, Beixin Rd., Xindian Dist. New Taipei 231 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain