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FDA 510(k)

Neptune E-SEP Smoke Evacuation Pencil

K-Number: K160693 · 2016-04-13

ApplicantStryker Corporation
Decision Date2016-04-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Neptune E-SEP Smoke Evacuation Pencil is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2016-04-13 under approval number K160693. 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 Neptune E-SEP Smoke Evacuation Pencil?

Neptune E-SEP Smoke Evacuation Pencil is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by Stryker Corporation. The 510(k) number is K160693.

When was Neptune E-SEP Smoke Evacuation Pencil approved by the FDA?

Neptune E-SEP Smoke Evacuation Pencil received FDA 510(k) clearance on 2016-04-13, under approval number K160693.

What company makes Neptune E-SEP Smoke Evacuation Pencil?

Neptune E-SEP Smoke Evacuation Pencil is manufactured by Stryker Corporation.

What is the FDA product code for Neptune E-SEP Smoke Evacuation Pencil?

The FDA product code for Neptune E-SEP Smoke Evacuation Pencil is GEI.

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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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