Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Single Use Aspiration Needle

K-Number: K190239 · 2019-12-10

Decision Date2019-12-10
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-12-10 under 510(k) number K190239. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Aspiration Needle?

Single Use Aspiration Needle is a medical device that received FDA 510(k) clearance on 2019-12-10. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K190239.

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

Single Use Aspiration Needle received FDA 510(k) clearance on 2019-12-10, under 510(k) number K190239.

Who is the listed applicant for Single Use Aspiration Needle?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Aspiration Needle?

The FDA product code for Single Use Aspiration Needle is KTI.

Other records listing Olympus Medical Systems Corp. 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.

View all 112 devices →

Related Devices (Code: KTI)

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

View on FDA Database →

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