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FDA 510(k)

TSolution One w/ACG+ Surgical System

K-Number: K153647 · 2016-02-16

ApplicantTHINK Surgical, Inc.
Decision Date2016-02-16
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TSolution One w/ACG+ Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is THINK Surgical, Inc.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153647. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSolution One w/ACG+ Surgical System?

TSolution One w/ACG+ Surgical System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is THINK Surgical, Inc.. The 510(k) number is K153647.

When did TSolution One w/ACG+ Surgical System receive FDA 510(k) clearance?

TSolution One w/ACG+ Surgical System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153647.

Who is the listed applicant for TSolution One w/ACG+ Surgical System?

The FDA 510(k) record lists THINK Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSolution One w/ACG+ Surgical System?

The FDA product code for TSolution One w/ACG+ Surgical System is OLO.

Other records listing THINK Surgical, Inc. as applicant

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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