Cadwell Sierra Summit, Cadwell Sierra Ascent
K-Number: K162383 · 2017-03-01
ApplicantCadwell Industries, Inc.
Decision Date2017-03-01
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Cadwell Sierra Summit, Cadwell Sierra Ascent is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2017-03-01 under approval number K162383. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cadwell Sierra Summit, Cadwell Sierra Ascent?
Cadwell Sierra Summit, Cadwell Sierra Ascent is a medical device that received FDA 510(k) clearance on 2017-03-01. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K162383.
When was Cadwell Sierra Summit, Cadwell Sierra Ascent approved by the FDA?
Cadwell Sierra Summit, Cadwell Sierra Ascent received FDA 510(k) clearance on 2017-03-01, under approval number K162383.
What company makes Cadwell Sierra Summit, Cadwell Sierra Ascent?
Cadwell Sierra Summit, Cadwell Sierra Ascent is manufactured by Cadwell Industries, Inc..
What is the FDA product code for Cadwell Sierra Summit, Cadwell Sierra Ascent?
The FDA product code for Cadwell Sierra Summit, Cadwell Sierra Ascent is IKN.
Other Devices by Cadwell Industries, Inc.
Related Devices (Code: IKN)
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.