FDA 510(k)

GDS-DC12

K-Number: K100135 · 2010-04-16

Decision Date2010-04-16

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GDS-DC12 is the device name listed in this FDA 510(k) record. The listed applicant is Guided Delivery Systems. It received FDA 510(k) clearance on 2010-04-16 under 510(k) number K100135. 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 GDS-DC12?

GDS-DC12 is a medical device that received FDA 510(k) clearance on 2010-04-16. The listed applicant is Guided Delivery Systems. The 510(k) number is K100135.

When did GDS-DC12 receive FDA 510(k) clearance?

GDS-DC12 received FDA 510(k) clearance on 2010-04-16, under 510(k) number K100135.

Who is the listed applicant for GDS-DC12?

The FDA 510(k) record lists Guided Delivery Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GDS-DC12?

The FDA product code for GDS-DC12 is DQY.

Other records listing Guided Delivery Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091367GDS-DCS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.