FDA 510(k)

Operio

K-Number: K173349 · 2017-12-20

Decision Date2017-12-20

Product CodeORC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Operio is the device name listed in this FDA 510(k) record. The listed applicant is Toul Meditech AB. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K173349. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Operio?

Operio is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Toul Meditech AB. The 510(k) number is K173349.

When did Operio receive FDA 510(k) clearance?

Operio received FDA 510(k) clearance on 2017-12-20, under 510(k) number K173349.

Who is the listed applicant for Operio?

The FDA 510(k) record lists Toul Meditech AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Operio?

The FDA product code for Operio is ORC.

Other records listing Toul Meditech AB as applicant

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.

K190027SteriStay K153498Operio

Related Devices (Code: ORC)

K190027SteriStayToul Meditech AB K163455SurgiCubeSurgicube International B.V.K153498OperioToul Meditech AB

Official Source

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