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FDA 510(k)

SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117

K-Number: K020821 · 2002-06-03

ApplicantBiotronik, Inc.
Decision Date2002-06-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2002-06-03 under 510(k) number K020821. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117?

SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 is a medical device that received FDA 510(k) clearance on 2002-06-03. The listed applicant is Biotronik, Inc.. The 510(k) number is K020821.

When did SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 receive FDA 510(k) clearance?

SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 received FDA 510(k) clearance on 2002-06-03, under 510(k) number K020821.

Who is the listed applicant for SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117?

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

What is the FDA product code for SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117?

The FDA product code for SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 is DQX.

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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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