Decision Date2016-04-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Neptune E-SEP Smoke Evacuation Pencil is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2016-04-13 under 510(k) 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. The listed applicant is Stryker Corporation. The 510(k) number is K160693.
When did Neptune E-SEP Smoke Evacuation Pencil receive FDA 510(k) clearance?
Neptune E-SEP Smoke Evacuation Pencil received FDA 510(k) clearance on 2016-04-13, under 510(k) number K160693.
Who is the listed applicant for Neptune E-SEP Smoke Evacuation Pencil?
The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.
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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Related Devices (Code: GEI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.