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FDA 510(k)

OptiVu™ Shoulder

K-Number: K252530 · 2025-09-10

ApplicantMr Surgical Solutions, LLC
Decision Date2025-09-10
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OptiVu™ Shoulder is a medical device manufactured by Mr Surgical Solutions, LLC. It received FDA 510(k) clearance on 2025-09-10 under approval number K252530. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiVu™ Shoulder?

OptiVu™ Shoulder is a medical device that received FDA 510(k) clearance on 2025-09-10. It is manufactured by Mr Surgical Solutions, LLC. The 510(k) number is K252530.

When was OptiVu™ Shoulder approved by the FDA?

OptiVu™ Shoulder received FDA 510(k) clearance on 2025-09-10, under approval number K252530.

What company makes OptiVu™ Shoulder?

OptiVu™ Shoulder is manufactured by Mr Surgical Solutions, LLC.

What is the FDA product code for OptiVu™ Shoulder?

The FDA product code for OptiVu™ Shoulder is SBF.

Other Devices by Mr Surgical Solutions, LLC

K252170OptiVu™ Shoulder K250108OptiVu™ Shoulder

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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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