THINK Surgical receives FDA 510(k) clearance for TMINI 1.1
[REGULATORY ACTION]Jun 15, 2026 · THINK Surgical · THINK Surgical TMINI · Fremont
Failure Mode
REGULATORY ACTION
Event Date
Jun 15, 2026
Primary Entity
THINK Surgical
Robotic Platform
THINK Surgical TMINI
Jurisdiction / Location
Fremont
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
THINK Surgical received second FDA 510(k) clearance for TMINI 1.1 Miniature Robotic System in less than 15 months.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://thinksurgical.com/think-surgical-receives-fda-510k-clearance-for-tmini-miniature-robotic-system-tmini-1-1/
https://thinksurgical.com/think-surgical-receives-fda-510k-clearance-for-tmini-miniature-robotic-system-tmini-1-1/
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Details
Incident Context & FAQ
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.