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FDA 510(k)

Faros Surgical System

K-Number: K233398 · 2024-06-27

ApplicantOertli Instrumente AG
Decision Date2024-06-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Faros Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Oertli Instrumente AG. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233398. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Faros Surgical System?

Faros Surgical System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Oertli Instrumente AG. The 510(k) number is K233398.

When did Faros Surgical System receive FDA 510(k) clearance?

Faros Surgical System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233398.

Who is the listed applicant for Faros Surgical System?

The FDA 510(k) record lists Oertli Instrumente AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Faros Surgical System?

The FDA product code for Faros Surgical System is HQC.

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Related Devices (Code: HQC)

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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