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FDA 510(k)

Celling Aspiration Needle

K-Number: K180807 · 2018-05-24

ApplicantSpine Smith Holdings, LLC
Decision Date2018-05-24
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Celling Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Spine Smith Holdings, LLC. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K180807. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celling Aspiration Needle?

Celling Aspiration Needle is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Spine Smith Holdings, LLC. The 510(k) number is K180807.

When did Celling Aspiration Needle receive FDA 510(k) clearance?

Celling Aspiration Needle received FDA 510(k) clearance on 2018-05-24, under 510(k) number K180807.

Who is the listed applicant for Celling Aspiration Needle?

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

What is the FDA product code for Celling Aspiration Needle?

The FDA product code for Celling Aspiration Needle is KNW.

Other records listing Spine Smith Holdings, LLC as applicant

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.

K193465CorticaLINK Spinal Fusion Platform

Related Devices (Code: KNW)

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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