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FDA 510(k)

Stellar LEAP

K-Number: K163432 · 2017-06-27

ApplicantPdg Product Design Group, Inc.
Decision Date2017-06-27
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Stellar LEAP is a medical device manufactured by Pdg Product Design Group, Inc.. It received FDA 510(k) clearance on 2017-06-27 under approval number K163432. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stellar LEAP?

Stellar LEAP is a medical device that received FDA 510(k) clearance on 2017-06-27. It is manufactured by Pdg Product Design Group, Inc.. The 510(k) number is K163432.

When was Stellar LEAP approved by the FDA?

Stellar LEAP received FDA 510(k) clearance on 2017-06-27, under approval number K163432.

What company makes Stellar LEAP?

Stellar LEAP is manufactured by Pdg Product Design Group, Inc..

What is the FDA product code for Stellar LEAP?

The FDA product code for Stellar LEAP is IOR.

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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.

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