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FDA 510(k)

Aspire Introducer Needle

K-Number: K180725 · 2018-07-11

Decision Date2018-07-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aspire Introducer Needle is the device name listed in this FDA 510(k) record. The listed applicant is Aspire Bariatrics, Inc.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K180725. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspire Introducer Needle?

Aspire Introducer Needle is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Aspire Bariatrics, Inc.. The 510(k) number is K180725.

When did Aspire Introducer Needle receive FDA 510(k) clearance?

Aspire Introducer Needle received FDA 510(k) clearance on 2018-07-11, under 510(k) number K180725.

Who is the listed applicant for Aspire Introducer Needle?

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

What is the FDA product code for Aspire Introducer Needle?

The FDA product code for Aspire Introducer Needle is KNT.

Other records listing Aspire Bariatrics, Inc. 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.

Related Devices (Code: KNT)

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.

Official Source

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