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FDA 510(k)

Entellus Medical Reinforced Anesthesia Needle

K-Number: K163435 · 2017-04-05

ApplicantEntellus Medical, Inc.
Decision Date2017-04-05
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Entellus Medical Reinforced Anesthesia Needle is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K163435. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Entellus Medical Reinforced Anesthesia Needle?

Entellus Medical Reinforced Anesthesia Needle is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K163435.

When did Entellus Medical Reinforced Anesthesia Needle receive FDA 510(k) clearance?

Entellus Medical Reinforced Anesthesia Needle received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163435.

Who is the listed applicant for Entellus Medical Reinforced Anesthesia Needle?

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

What is the FDA product code for Entellus Medical Reinforced Anesthesia Needle?

The FDA product code for Entellus Medical Reinforced Anesthesia Needle is BSP.

Other records listing Entellus Medical, Inc. as applicant

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Related Devices (Code: BSP)

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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