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

FDA 510(k)

Safety Subcutaneous Infusion Set

K-Number: K201626 · 2021-03-24

Decision Date2021-03-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Subcutaneous Infusion Set is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2021-03-24 under approval number K201626. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Subcutaneous Infusion Set?

Safety Subcutaneous Infusion Set is a medical device that received FDA 510(k) clearance on 2021-03-24. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K201626.

When was Safety Subcutaneous Infusion Set approved by the FDA?

Safety Subcutaneous Infusion Set received FDA 510(k) clearance on 2021-03-24, under approval number K201626.

What company makes Safety Subcutaneous Infusion Set?

Safety Subcutaneous Infusion Set is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for Safety Subcutaneous Infusion Set?

The FDA product code for Safety Subcutaneous Infusion Set is FPA.

Related Clinical Trials

Other Devices by Epic Medical Pte. , Ltd.

View all 21 devices →

Related Devices (Code: FPA)

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.