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)

Smart Set

K-Number: K151250 · 2016-06-07

Decision Date2016-06-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Smart Set is a medical device manufactured by Top Spins, Inc.. It received FDA 510(k) clearance on 2016-06-07 under approval number K151250. 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 Smart Set?

Smart Set is a medical device that received FDA 510(k) clearance on 2016-06-07. It is manufactured by Top Spins, Inc.. The 510(k) number is K151250.

When was Smart Set approved by the FDA?

Smart Set received FDA 510(k) clearance on 2016-06-07, under approval number K151250.

What company makes Smart Set?

Smart Set is manufactured by Top Spins, Inc..

What is the FDA product code for Smart Set?

The FDA product code for Smart Set is FPA.

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.