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FDA 510(k)

Optimized Positioning System (OPS) Insight

K-Number: K202805 · 2020-11-20

ApplicantCorin USA
Decision Date2020-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optimized Positioning System (OPS) Insight is a medical device manufactured by Corin USA. It received FDA 510(k) clearance on 2020-11-20 under approval number K202805. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optimized Positioning System (OPS) Insight?

Optimized Positioning System (OPS) Insight is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Corin USA. The 510(k) number is K202805.

When was Optimized Positioning System (OPS) Insight approved by the FDA?

Optimized Positioning System (OPS) Insight received FDA 510(k) clearance on 2020-11-20, under approval number K202805.

What company makes Optimized Positioning System (OPS) Insight?

Optimized Positioning System (OPS) Insight is manufactured by Corin USA.

What is the FDA product code for Optimized Positioning System (OPS) Insight?

The FDA product code for Optimized Positioning System (OPS) Insight is LLZ.

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Other Devices by Corin USA

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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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