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FDA 510(k)

IGUIDE CAPPA

K-Number: K093787 · 2010-03-11

ApplicantCas Innovations GmbH & Co. KG
Decision Date2010-03-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IGUIDE CAPPA is the device name listed in this FDA 510(k) record. The listed applicant is Cas Innovations GmbH & Co. KG. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K093787. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGUIDE CAPPA?

IGUIDE CAPPA is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Cas Innovations GmbH & Co. KG. The 510(k) number is K093787.

When did IGUIDE CAPPA receive FDA 510(k) clearance?

IGUIDE CAPPA received FDA 510(k) clearance on 2010-03-11, under 510(k) number K093787.

Who is the listed applicant for IGUIDE CAPPA?

The FDA 510(k) record lists Cas Innovations GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGUIDE CAPPA?

The FDA product code for IGUIDE CAPPA is JAK.

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Related Devices (Code: JAK)

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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.

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