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TSolution One Surgical System Model 210

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170430

by Think Surgical, Inc.

Identifiers

510(k) Number
K170430 FDA 510(k)
FDA Product Code
OLO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TSolution One Surgical System Model 210 by Think Surgical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K170430 24 fields · synced Jun 19, 2026