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)

ProSeal™ Injection Site Extended Male Luer Lock (422140)

K-Number: K240433 · 2024-05-21

Decision Date2024-05-21
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProSeal™ Injection Site Extended Male Luer Lock (422140) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K240433. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSeal™ Injection Site Extended Male Luer Lock (422140)?

ProSeal™ Injection Site Extended Male Luer Lock (422140) is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K240433.

When did ProSeal™ Injection Site Extended Male Luer Lock (422140) receive FDA 510(k) clearance?

ProSeal™ Injection Site Extended Male Luer Lock (422140) received FDA 510(k) clearance on 2024-05-21, under 510(k) number K240433.

Who is the listed applicant for ProSeal™ Injection Site Extended Male Luer Lock (422140)?

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

What is the FDA product code for ProSeal™ Injection Site Extended Male Luer Lock (422140)?

The FDA product code for ProSeal™ Injection Site Extended Male Luer Lock (422140) is ONB.

Other records listing Epic Medical Pte. , Ltd. 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 22 devices →

Related Devices (Code: ONB)

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.