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FDA 510(k)

Super Distal Access (SDA)

K-Number: K161262 · 2016-09-19

ApplicantInneuroco, Inc.
Decision Date2016-09-19
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Super Distal Access (SDA) is a medical device manufactured by Inneuroco, Inc.. It received FDA 510(k) clearance on 2016-09-19 under approval number K161262. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Super Distal Access (SDA)?

Super Distal Access (SDA) is a medical device that received FDA 510(k) clearance on 2016-09-19. It is manufactured by Inneuroco, Inc.. The 510(k) number is K161262.

When was Super Distal Access (SDA) approved by the FDA?

Super Distal Access (SDA) received FDA 510(k) clearance on 2016-09-19, under approval number K161262.

What company makes Super Distal Access (SDA)?

Super Distal Access (SDA) is manufactured by Inneuroco, Inc..

What is the FDA product code for Super Distal Access (SDA)?

The FDA product code for Super Distal Access (SDA) is DQY.

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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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