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TMINI Miniature Robotic System

by Think Surgical Inc. 2 variants

510(k) K261024

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK261024 Date24 Jul 2026ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0192-2027 FDA Not yet classified initiated 20 Aug 2026

    Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLO
FDA applicant
THINK Surgical, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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