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FDA 510(k)

Sapphire II PRO

K-Number: K163114 · 2017-01-05

ApplicantOrbusneich Medical, Inc.
Decision Date2017-01-05
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sapphire II PRO is the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical, Inc.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K163114. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sapphire II PRO?

Sapphire II PRO is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Orbusneich Medical, Inc.. The 510(k) number is K163114.

When did Sapphire II PRO receive FDA 510(k) clearance?

Sapphire II PRO received FDA 510(k) clearance on 2017-01-05, under 510(k) number K163114.

Who is the listed applicant for Sapphire II PRO?

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

What is the FDA product code for Sapphire II PRO?

The FDA product code for Sapphire II PRO is LOX.

Other records listing Orbusneich Medical, Inc. 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.

K162209Sapphire NC Plus

Related Devices (Code: LOX)

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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