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FDA 510(k)

SINUFLUSH LAVAGE SYSTEM

K-Number: K131177 · 2013-09-20

ApplicantHedgepath, LLC
Decision Date2013-09-20
Product CodeKAR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUFLUSH LAVAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hedgepath, LLC. It received FDA 510(k) clearance on 2013-09-20 under 510(k) number K131177. The device is classified under product code KAR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINUFLUSH LAVAGE SYSTEM?

SINUFLUSH LAVAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-20. The listed applicant is Hedgepath, LLC. The 510(k) number is K131177.

When did SINUFLUSH LAVAGE SYSTEM receive FDA 510(k) clearance?

SINUFLUSH LAVAGE SYSTEM received FDA 510(k) clearance on 2013-09-20, under 510(k) number K131177.

Who is the listed applicant for SINUFLUSH LAVAGE SYSTEM?

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

What is the FDA product code for SINUFLUSH LAVAGE SYSTEM?

The FDA product code for SINUFLUSH LAVAGE SYSTEM is KAR.

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Related Devices (Code: KAR)

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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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