DeviceClearance

TMINI Miniature Robotic System— 510(k) K261024

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.

Summary

THINK Surgical's TMINI Miniature Robotic System is filed under OLO, orthopedic stereotaxic instruments. The record doesn't list the system's components.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

THINK Surgical filed from Fremont, California. The decision came 116 calendar days after FDA received it (March 30 to July 24, 2026).

Clearance details

Applicant
THINK Surgical, Inc.
Product code
Product code OLO
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fremont, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OLO

view all

More clearances from THINK Surgical, Inc.

view all

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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K261024

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K261024.

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