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Incident · Regulatory action

THINK Surgical receives FDA 510(k) clearance for TMINI 1.1

THINK Surgical received second FDA 510(k) clearance for TMINI 1.1 Miniature Robotic System in less than 15 months.

Occurred 2026-06-15 · THINK Surgical TMINI at Fremont · THINK Surgical · Fremont · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (2)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260010.pdf · 2026-01-08
  2. https://thinksurgical.com/think-surgical-receives-fda-510k-clearance-for-tmini-miniature-robotic-system-tmini-1-1/

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in THINK Surgical receives FDA 510(k) clearance for TMINI 1.1?
THINK Surgical received second FDA 510(k) clearance for TMINI 1.1 Miniature Robotic System in less than 15 months.
When did this incident occur?
The incident is recorded as occurring on June 15, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in THINK Surgical receives FDA 510(k) clearance for TMINI 1.1?
THINK Surgical TMINI by THINK Surgical is the recorded robot involved in this incident at Fremont.
Has anyone responded to THINK Surgical receives FDA 510(k) clearance for TMINI 1.1?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of THINK Surgical receives FDA 510(k) clearance for TMINI 1.1?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-07-14

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

1
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for THINK Surgical receives FDA 510(k) clearance for TMINI 1.1.

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Canonical ID 568e84d3-d723-4e72-be68-025e42d681a9