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FDA 510(k)

Genteel Lancing Device

K-Number: K153670 · 2016-05-12

ApplicantGenteel, LLC
Decision Date2016-05-12
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Genteel Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Genteel, LLC. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K153670. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genteel Lancing Device?

Genteel Lancing Device is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Genteel, LLC. The 510(k) number is K153670.

When did Genteel Lancing Device receive FDA 510(k) clearance?

Genteel Lancing Device received FDA 510(k) clearance on 2016-05-12, under 510(k) number K153670.

Who is the listed applicant for Genteel Lancing Device?

The FDA 510(k) record lists Genteel, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genteel Lancing Device?

The FDA product code for Genteel Lancing Device is FMK.

Related Devices (Code: FMK)

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

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

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