FDA 510(k)

THUNDERBEAT Open Fine Jaw

K-Number: K151743 · 2016-02-26

Decision Date2016-02-26

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

THUNDERBEAT Open Fine Jaw is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-02-26 under approval number K151743. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THUNDERBEAT Open Fine Jaw?

THUNDERBEAT Open Fine Jaw is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K151743.

When was THUNDERBEAT Open Fine Jaw approved by the FDA?

THUNDERBEAT Open Fine Jaw received FDA 510(k) clearance on 2016-02-26, under approval number K151743.

What company makes THUNDERBEAT Open Fine Jaw?

THUNDERBEAT Open Fine Jaw is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for THUNDERBEAT Open Fine Jaw?

The FDA product code for THUNDERBEAT Open Fine Jaw is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.