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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 a medical device manufactured by Entellus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval 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. It is manufactured by Entellus Medical, Inc.. The 510(k) number is K163435.

When was Entellus Medical Reinforced Anesthesia Needle approved by the FDA?

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

What company makes Entellus Medical Reinforced Anesthesia Needle?

Entellus Medical Reinforced Anesthesia Needle is manufactured by Entellus Medical, Inc..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41034609 Influence of geometry, reinforcement, and sterilisation on the dimensional accuracy of additively manufactured carbon fibre-reinforced nylon composites. Scientific reports (2025) PMID: 40487675 Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea. Obesity pillars (2025)

Other Devices by Entellus Medical, Inc.

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Related Devices (Code: BSP)

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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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