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FDA 510(k)

OpClear System

K-Number: K171637 · 2018-02-26

ApplicantCipher Surgical, Ltd.
Decision Date2018-02-26
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OpClear System is a medical device manufactured by Cipher Surgical, Ltd.. It received FDA 510(k) clearance on 2018-02-26 under approval number K171637. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OpClear System?

OpClear System is a medical device that received FDA 510(k) clearance on 2018-02-26. It is manufactured by Cipher Surgical, Ltd.. The 510(k) number is K171637.

When was OpClear System approved by the FDA?

OpClear System received FDA 510(k) clearance on 2018-02-26, under approval number K171637.

What company makes OpClear System?

OpClear System is manufactured by Cipher Surgical, Ltd..

What is the FDA product code for OpClear System?

The FDA product code for OpClear System is OCX.

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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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