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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 the device name listed in this FDA 510(k) record. The listed applicant is Inneuroco, Inc.. It received FDA 510(k) clearance on 2016-09-19 under 510(k) 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. The listed applicant is Inneuroco, Inc.. The 510(k) number is K161262.

When did Super Distal Access (SDA) receive FDA 510(k) clearance?

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

Who is the listed applicant for Super Distal Access (SDA)?

The FDA 510(k) record lists Inneuroco, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Inneuroco, Inc. as applicant

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Related Devices (Code: 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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