FDA 510(k)

EPIC Extremely Small Staple

K-Number: K163226 · 2017-05-16

Decision Date2017-05-16

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EPIC Extremely Small Staple is a medical device manufactured by Epic Extremely, LLC. It received FDA 510(k) clearance on 2017-05-16 under approval number K163226. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIC Extremely Small Staple?

EPIC Extremely Small Staple is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Epic Extremely, LLC. The 510(k) number is K163226.

When was EPIC Extremely Small Staple approved by the FDA?

EPIC Extremely Small Staple received FDA 510(k) clearance on 2017-05-16, under approval number K163226.

What company makes EPIC Extremely Small Staple?

EPIC Extremely Small Staple is manufactured by Epic Extremely, LLC.

What is the FDA product code for EPIC Extremely Small Staple?

The FDA product code for EPIC Extremely Small Staple is JDR.

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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.