TMINI Miniature Robotic System— 510(k) K261024

Name: FDA 510(k) clearance K261024
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

THINK Surgical, Inc.

FDA 510(k) clearance K261024 for TMINI Miniature Robotic System, Substantially Equivalent on 2026-07-24. Applicant: THINK Surgical, Inc.. Device class: 2.

Clearance details

Applicant: THINK Surgical, Inc.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-03-30
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262121 — Ion-L Navigated Instruments2026-07-24
K261113 — Op.n Spine Navigation and Robotic Guidance2026-07-22
K261852 — OTS Hip2026-07-01
K253921 — VERTICALE® Navigation Instruments2026-06-26
K260480 — VELYS Robotic-Assisted Solution2026-06-25

More clearances from THINK Surgical, Inc.

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K260010 — TMINI® Miniature Robotic System2026-03-03
K253661 — TMINI Miniature Robotic System2025-12-22
K252544 — TMINI Miniature Robotic System2025-10-10
K250877 — TMINI Miniature Robotic System2025-06-20
K243481 — TMINI Miniature Robotic System2025-01-06

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.